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Document L:2022:190:FULL

Official Journal of the European Union, L 190, 19 July 2022


Display all documents published in this Official Journal
 

ISSN 1977-0677

Official Journal

of the European Union

L 190

European flag  

English edition

Legislation

Volume 65
19 July 2022


Contents

 

II   Non-legislative acts

page

 

 

REGULATIONS

 

*

Council Implementing Regulation (EU) 2022/1230 of 18 July 2022 implementing Article 2(3) of Regulation (EC) No 2580/2001 on specific restrictive measures directed against certain persons and entities with a view to combating terrorism, and repealing Implementing Regulation (EU) 2022/147

1

 

*

Council Implementing Regulation (EU) 2022/1231 of 18 July 2022 implementing Regulation (EC) No 765/2006 concerning restrictive measures in view of the situation in Belarus and the involvement of Belarus in the Russian aggression against Ukraine

5

 

*

Commission Implementing Regulation (EU) 2022/1232 of 13 July 2022 granting a Union authorisation for the biocidal product family INTEROX Biocidal Product Family 1 ( 1 )

7

 

*

Commission Implementing Regulation (EU) 2022/1233 of 18 July 2022 amending Implementing Regulation (EU) 2020/492 imposing definitive anti-dumping duties on imports of certain woven and/or stitched glass fibre fabrics originating in the People’s Republic of China and Egypt

70

 

*

Commission Implementing Regulation (EU) 2022/1234 of 18 July 2022 amending Annex I to Implementing Regulation (EU) 2021/605 laying down special control measures for African swine fever ( 1 )

79

 

 

DECISIONS

 

*

Council Decision (EU) 2022/1235 of 12 July 2022 concerning the renewal of the Agreement for scientific and technological cooperation between the European Community and the Federative Republic of Brazil

119

 

*

Council Decision (CFSP) 2022/1236 of 18 July 2022 on an assistance measure under the European Peace Facility to support the Nigerien Armed Forces

121

 

*

Council Decision (CFSP) 2022/1237 of 18 July 2022 amending Decision (CFSP) 2018/907 extending the mandate of the European Union Special Representative for the South Caucasus and the crisis in Georgia

125

 

*

Council Decision (CFSP) 2022/1238 of 18 July 2022 extending the mandate of the European Union Special Representative for the Horn of Africa and amending Decision (CFSP) 2021/1012

127

 

*

Council Decision (CFSP) 2022/1239 of 18 July 2022 extending the mandate of the European Union Special Representative for the Sahel and amending Decision (CFSP) 2021/1011

129

 

*

Council Decision (CFSP) 2022/1240 of 18 July 2022 amending Decision (CFSP) 2020/489 appointing the European Union Special Representative for the Belgrade-Pristina Dialogue and other Western Balkan regional issues

131

 

*

Council Decision (CFSP) 2022/1241 of 18 July 2022 updating the list of persons, groups and entities subject to Articles 2, 3 and 4 of Common Position 2001/931/CFSP on the application of specific measures to combat terrorism, and repealing Decision (CFSP) 2022/152

133

 

*

Council Decision (EU) 2022/1242 of 18 July 2022 amending the Council’s Rules of Procedure

137

 

*

Council Implementing Decision (CFSP) 2022/1243 of 18 July 2022 implementing Decision 2012/642/CFSP concerning restrictive measures in view of the situation in Belarus and the involvement of Belarus in the Russian aggression against Ukraine

139

 

*

Commission Decision (EU) 2022/1244 of 13 July 2022 establishing the EU Ecolabel criteria for growing media and soil improvers (notified under document C(2022) 4758)  ( 1 )

141

 

*

Commission Implementing Decision (EU) 2022/1245 of 15 July 2022 laying down rules and procedures for the application of Regulation (EU) 2021/696 of the European Parliament and of the Council as regards the participation of Member States in the SST sub-component, the establishment of the SST Partnership and the development of the initial key performance indicators

166

 

 

Corrigenda

 

*

Corrigendum to Council Regulation (EU) 2022/576 of 8 April 2022 amending Regulation (EU) No 833/2014 concerning restrictive measures in view of Russia’s actions destabilising the situation in Ukraine ( OJ L 111, 8.4.2022 )

191

 


 

(1)   Text with EEA relevance.

EN

Acts whose titles are printed in light type are those relating to day-to-day management of agricultural matters, and are generally valid for a limited period.

The titles of all other Acts are printed in bold type and preceded by an asterisk.


II Non-legislative acts

REGULATIONS

19.7.2022   

EN

Official Journal of the European Union

L 190/1


COUNCIL IMPLEMENTING REGULATION (EU) 2022/1230

of 18 July 2022

implementing Article 2(3) of Regulation (EC) No 2580/2001 on specific restrictive measures directed against certain persons and entities with a view to combating terrorism, and repealing Implementing Regulation (EU) 2022/147

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Council Regulation (EC) No 2580/2001 of 27 December 2001 on specific restrictive measures directed against certain persons and entities with a view to combating terrorism (1), and in particular Article 2(3) thereof,

Having regard to the proposal from the High Representative of the Union for Foreign Affairs and Security Policy,

Whereas:

(1)

On 3 February 2022, the Council adopted Implementing Regulation (EU) 2022/147 (2), implementing Article 2(3) of Regulation (EC) No 2580/2001 and establishing an updated list of persons, groups and entities to which Regulation (EC) No 2580/2001 applies (‘the list’).

(2)

The Council has provided, where practically possible, all the persons, groups and entities with statements of reasons explaining why they were entered into the list.

(3)

By way of a notice published in the Official Journal of the European Union, the Council informed the persons, groups and entities on the list that it had decided to keep them thereon. The Council also informed those persons, groups and entities concerned that it was possible to request a statement of the Council’s reasons for entering them into the list where such a statement had not already been communicated to them.

(4)

The Council has reviewed the list as required by Article 2(3) of Regulation (EC) No 2580/2001. When carrying out that review, the Council took into account the observations submitted to it by those concerned as well as the updated information received from the competent national authorities on the status of listed individuals and entities at the national level.

(5)

The Council has verified that competent authorities, as referred to in Article 1(4) of Council Common Position 2001/931/CFSP (3), have taken decisions with regard to all persons, groups and entities on the list to the effect that they have been involved in terrorist acts within the meaning of Article 1(2) and (3) of Common Position 2001/931/CFSP. The Council has also concluded that the persons, groups and entities to which Articles 2, 3 and 4 of Common Position 2001/931/CFSP apply should continue to be subject to the specific restrictive measures provided for in Regulation (EC) No 2580/2001.

(6)

The list should be updated accordingly and Implementing Regulation (EU) 2022/147 should be repealed,

HAS ADOPTED THIS REGULATION:

Article 1

The list provided for in Article 2(3) of Regulation (EC) No 2580/2001 is set out in the Annex to this Regulation.

Article 2

Implementing Regulation (EU) 2022/147 is hereby repealed.

Article 3

This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 18 July 2022.

For the Council

The President

J. BORRELL FONTELLES


(1)  OJ L 344, 28.12.2001, p. 70.

(2)  Council Implementing Regulation (EU) 2022/147 of 3 February 2022 implementing Article 2(3) of Regulation (EC) No 2580/2001 on specific restrictive measures directed against certain persons and entities with a view to combating terrorism, and repealing Implementing Regulation (EU) 2021/1188 (OJ L 25, 4.2.2022, p. 1).

(3)  Council Common Position 2001/931/CFSP of 27 December 2001 on the application of specific measures to combat terrorism (OJ L 344, 28.12.2001, p. 93).


ANNEX

LIST OF PERSONS, GROUPS AND ENTITIES REFERRED TO IN ARTICLE 1

I.   PERSONS

1.

ABDOLLAHI Hamed (a.k.a. Mustafa Abdullahi), born 11.8.1960 in Iran. Passport number: D9004878.

2.

AL-NASSER Abdelkarim Hussein Mohamed, born in Al Ihsa (Saudi Arabia), citizen of Saudi Arabia.

3.

AL-YACOUB Ibrahim Salih Mohammed, born 16.10.1966 in Tarut (Saudi Arabia), citizen of Saudi Arabia.

4.

ARBABSIAR Manssor (a.k.a. Mansour Arbabsiar), born 6.3.1955 or 15.3.1955 in Iran. Iranian and US national, Passport number: C2002515 (Iran); Passport number: 477845448 (USA). National ID number: 07442833, expiry date 15.3.2016 (USA driving licence).

5.

ASSADI Assadollah (a.k.a. Assadollah Asadi), born 22.12.1971 in Teheran (Iran), Iranian national. Iranian diplomatic passport number: D9016657.

6.

BOUYERI Mohammed (a.k.a. Abu Zubair, a.k.a. Sobiar, a.k.a. Abu Zoubair), born 8.3.1978 in Amsterdam (The Netherlands).

7.

EL HAJJ Hassan Hassan, born 22.3.1988 in Zaghdraiya, Sidon, Lebanon, Canadian citizen. Passport number: JX446643 (Canada).

8.

HASHEMI MOGHADAM Saeid, born 6.8.1962 in Teheran (Iran), Iranian national. Passport number: D9016290, valid until 4.2.2019.

9.

AL-DIN Izz Hasan (a.k.a. Garbaya Ahmed, a.k.a. Sa’id, a.k.a. Salwwan Samir), Lebanon, born 1963 in Lebanon, citizen of Lebanon.

10.

MELIAD Farah, born 5.11.1980 in Sydney (Australia), Australian citizen. Passport number: M2719127 (Australia).

11.

MOHAMMED Khalid Sheikh (a.k.a. Ali Salem, a.k.a. Bin Khalid Fahd Bin Abdallah, a.k.a. Henin Ashraf Refaat Nabith, a.k.a. Wadood Khalid Abdul), born 14.4.1965 or 1.3.1964 in Pakistan, passport number 488555.

12.

SHAHLAI Abdul Reza (a.k.a. Abdol Reza Shala’i, a.k.a. Abd-al Reza Shalai, a.k.a. Abdorreza Shahlai, a.k.a. Abdolreza Shahla’i, a.k.a. Abdul-Reza Shahlaee, a.k.a. Hajj Yusef, a.k.a. Haji Yusif, a.k.a. Hajji Yasir, a.k.a. Hajji Yusif, a.k.a. Yusuf Abu-al-Karkh), born circa 1957 in Iran. Addresses: (1) Kermanshah, Iran, (2) Mehran Military Base, Ilam Province, Iran.

13.

SHAKURI Ali Gholam, born circa 1965 in Tehran, Iran.

II.   GROUPS AND ENTITIES

1.

‘Abu Nidal Organisation’ – ‘ANO’ (a.k.a. ‘Fatah Revolutionary Council’, a.k.a. ‘Arab Revolutionary Brigades’, a.k.a. ‘Black September’, a.k.a. ‘Revolutionary Organisation of Socialist Muslims’).

2.

‘Al-Aqsa Martyrs’ Brigade’.

3.

‘Al-Aqsa e.V.’.

4.

‘Babbar Khalsa’.

5.

‘Communist Party of the Philippines’, including ‘New People’s Army’ – ‘NPA’, Philippines.

6.

Directorate for Internal Security of the Iranian Ministry for Intelligence and Security.

7.

‘Gama’a al-Islamiyya’ (a.k.a. ‘Al-Gama’a al-Islamiyya’) (‘Islamic Group’ – ‘IG’).

8.

‘İslami Büyük Doğu Akıncılar Cephesi’ – ‘IBDA-C’ (‘Great Islamic Eastern Warriors Front’).

9.

‘Hamas’, including ‘Hamas-Izz al-Din al-Qassem’.

10.

‘Hizballah Military Wing’ (a.k.a. ‘Hezbollah Military Wing’, a.k.a. ‘Hizbullah Military Wing’, a.k.a. ‘Hizbollah Military Wing’, a.k.a. ‘Hezballah Military Wing’, a.k.a. ‘Hisbollah Military Wing’, a.k.a. ‘Hizbu’llah Military Wing’ a.k.a. ‘Hizb Allah Military Wing’, a.k.a. ‘Jihad Council’ (and all units reporting to it, including the External Security Organisation)).

11.

‘Hizbul Mujahideen’ – ‘HM’.

12.

‘Khalistan Zindabad Force’ – ‘KZF’.

13.

‘Kurdistan Workers’ Party’ – ‘PKK’ (a.k.a. ‘KADEK’, a.k.a. ‘KONGRA-GEL’).

14.

‘Liberation Tigers of Tamil Eelam’ – ‘LTTE’.

15.

‘Ejército de Liberación Nacional’ (‘National Liberation Army’).

16.

‘Palestinian Islamic Jihad’ – ‘PIJ’.

17.

‘Popular Front for the Liberation of Palestine’ – ‘PFLP’.

18.

‘Popular Front for the Liberation of Palestine – General Command’ (a.k.a. ‘PFLP – General Command’).

19.

‘Devrimci Halk Kurtuluș Partisi-Cephesi’ – ‘DHKP/C’ (a.k.a. ‘Devrimci Sol’ (‘Revolutionary Left’), a.k.a. ‘Dev Sol’) (‘Revolutionary People’s Liberation Army/Front/Party’).

20.

‘Sendero Luminoso’ – ‘SL’ (‘Shining Path’).

21.

‘Teyrbazen Azadiya Kurdistan’ – ‘TAK’ (a.k.a. ‘Kurdistan Freedom Falcons’, a.k.a. ‘Kurdistan Freedom Hawks’).

19.7.2022   

EN

Official Journal of the European Union

L 190/5


COUNCIL IMPLEMENTING REGULATION (EU) 2022/1231

of 18 July 2022

implementing Regulation (EC) No 765/2006 concerning restrictive measures in view of the situation in Belarus and the involvement of Belarus in the Russian aggression against Ukraine

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Council Regulation (EC) No 765/2006 of 18 May 2006 concerning restrictive measures in view of the situation in Belarus and the involvement of Belarus in the Russian aggression against Ukraine (1), and in particular Article 8a(3) thereof,

Having regard to the proposal from the High Representative of the Union for Foreign Affairs and Security Policy,

Whereas:

(1)

On 18 May 2006, the Council adopted Regulation (EC) No 765/2006.

(2)

Further to an evaluation of the relevant circumstances, one entry should be deleted from the list of natural and legal persons, entities and bodies set out in Annex I to Regulation (EC) No 765/2006.

(3)

Regulation (EC) No 765/2006 should therefore be amended accordingly,

HAS ADOPTED THIS REGULATION:

Article 1

Annex I to Regulation (EC) No 765/2006 is amended in accordance with the Annex to this Regulation.

Article 2

This Regulation shall enter into force on the date following that of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 18 July 2022.

For the Council

The President

J. BORRELL FONTELLES


(1)  OJ L 134, 20.5.2006, p. 1.


ANNEX

The following entry is deleted from the list set out in Section B (‘Legal persons, entities and bodies referred to in Article 2(1)’) of Annex I to Regulation (EC) No 765/2006:

‘23.

Cham Wings Airlines’.


19.7.2022   

EN

Official Journal of the European Union

L 190/7


COMMISSION IMPLEMENTING REGULATION (EU) 2022/1232

of 13 July 2022

granting a Union authorisation for the biocidal product family ‘INTEROX Biocidal Product Family 1’

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (1), and in particular the Article 44(5), first subparagraph, thereof,

Whereas:

(1)

On 25 January 2017, Solvay Chemicals International S.A. submitted an application, in accordance with Article 43(1) of Regulation (EU) No 528/2012, for authorisation of a biocidal product family named ‘INTEROX Biocidal Product Family 1’ of product-types 2, 3 and 4, as described in Annex V to that Regulation, providing written confirmation that the competent authority of Finland had agreed to evaluate the application. The application was recorded under case number BC-WX029254-02 in the Register for Biocidal Products.

(2)

‘INTEROX Biocidal Product Family 1’ contains hydrogen peroxide as the active substance, which is included in the Union list of approved active substance referred to in Article 9(2) of Regulation (EU) No 528/2012 for product-types 2, 3 and 4.

(3)

On 21 April 2021, the evaluating competent authority submitted, in accordance with Article 44(1) of Regulation (EU) No 528/2012, an assessment report and the conclusions of its evaluation to the European Chemicals Agency (‘the Agency’).

(4)

On 4 November 2021, the Agency submitted to the Commission an opinion (2), including the draft summary of the biocidal product characteristics (‘SPC’) of ‘INTEROX Biocidal Product Family 1’ and the final assessment report on the biocidal product family in accordance with Article 44(3) of Regulation (EU) No 528/2012.

(5)

The opinion concludes that ‘INTEROX Biocidal Product Family 1’ is a ‘biocidal product family’ within the meaning of Article 3(1), point (s), of Regulation (EU) No 528/2012, that it is eligible for Union authorisation in accordance with Article 42(1) of that Regulation and that subject to compliance with the draft SPC, it meets the conditions laid down in Article 19(1) and (6) of that Regulation.

(6)

On 16 November 2021, the Agency transmitted to the Commission the draft SPC in all the official languages of the Union in accordance with Article 44(4) of Regulation (EU) No 528/2012.

(7)

The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for ‘INTEROX Biocidal Product Family 1’.

(8)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on biocidal products,

HAS ADOPTED THIS REGULATION:

Article 1

A Union authorisation with authorisation number EU-0027468-0000 is granted to Solvay Chemicals International S.A. for the making available on the market and use of the biocidal product family ‘INTEROX Biocidal Product Family 1’ in accordance with the summary of the biocidal product characteristics set out in the Annex.

The Union Authorisation is valid from 8 August 2022 to 31 July 2032.

Article 2

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 13 July 2022.

For the Commission

The President

Ursula VON DER LEYEN


(1)  OJ L 167, 27.6.2012, p. 1.

(2)  ECHA opinion of 13 October 2021 on the Union authorisation of ‘INTEROX Biocidal Product Family 1’ (ECHA/BPC/295/2021), https://echa.europa.eu/bpc-opinions-on-union-authorisation


ANNEX

Summary of product characteristics for a biocidal product family

Interox Biocidal Product Family 1

Product type 2 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

Product type 3 - Veterinary hygiene (Disinfectants)

Product type 4 - Food and feed area (Disinfectants)

Authorisation number: EU-0027468-0000

R4BP asset number: EU-0027468-0000

PART I

FIRST INFORMATION LEVEL

1.   ADMINISTRATIVE INFORMATION

1.1.   Family name

Name

Interox Biocidal Product Family 1

1.2.   Product type(s)

Product type(s)

PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

PT03 - Veterinary hygiene (Disinfectants)

PT04 - Food and feed area (Disinfectants)

1.3.   Authorisation holder

Name and address of the authorisation holder

Name

SOLVAY CHEMICALS INTERNATIONAL

Address

RUE DE RANSBEEK 310, B-1120 BRUXELLES Belgium

Authorisation number

EU-0027468-0000

R4BP asset number

EU-0027468-0000

Date of the authorisation

8 August 2022

Expiry date of the authorisation

31 July 2032

1.4.   Manufacturer(s) of the biocidal products

Name of manufacturer

Solvay Interox Limited

Address of manufacturer

Baronet Road, Solvay House, WA4 6HA Warrington United Kingdom

Location of manufacturing sites

Solvay Interox Limited, Baronet Road, Solvay House, WA4 6HA Warrington United Kingdom


Name of manufacturer

Solvay Chemicals Finland Oy

Address of manufacturer

YRJONOJANTIE 2, 45910 VOIKKAA Finland

Location of manufacturing sites

Solvay Chemicals Finland Oy, YRJONOJANTIE 2, 45910 VOIKKAA Finland


Name of manufacturer

Solvay Chemicals GmbH Germany

Address of manufacturer

KOETHENSCHE STRASSE 1-3, 06406 DE BERNBURG Germany

Location of manufacturing sites

Solvay Chemicals GmbH Germany, KOETHENSCHE STRASSE 1-3, 06406 DE BERNBURG Germany


Name of manufacturer

Solvay Chemie BV Netherlands

Address of manufacturer

SCHEPERSWEG, 1, 6049 CV HERTEN Netherlands

Location of manufacturing sites

Solvay Chemie BV Netherlands, SCHEPERSWEG, 1, 6049 CV HERTEN Netherlands


Name of manufacturer

Solvay Chimica Italia SpA Italy

Address of manufacturer

VIA PIAVE, 6 Rosignano SOLVAY, LI 57013 Rosignano Italy

Location of manufacturing sites

Solvay Chimica Italia SpA Italy, VIA PIAVE, 6 Rosignano SOLVAY, LI 57013 Rosignano Italy


Name of manufacturer

Solvay Chimie SA Belgium

Address of manufacturer

Rue de Ransbeek 310, 1120 BE Brussels Belgium

Location of manufacturing sites

Solvay Chimie SA Belgium, RUE SOLVAY, 39, 5190 BE JEMEPPE-SUR-SAMBRE Belgium

Solvay Chimie SA Belgium, SCHELDELAAN 600 – HAVEN 725, 2040 BE Antwerp Belgium


Name of manufacturer

Solvay Interox Produtos Peroxidados SA

Address of manufacturer

RUA ENG. CLEMENT DUMOULIN, 2625-106 POVOA DE SANTA IRIA Portugal

Location of manufacturing sites

Solvay Interox Produtos Peroxidados SA, RUA ENG. CLEMENT DUMOULIN, 2625-106 POVOA DE SANTA IRIA Portugal

1.5.   Manufacturer(s) of the active substance(s)

Active substance

Hydrogen peroxide

Name of manufacturer

Solvay Interox Limited

Address of manufacturer

Baronet Road, Solvay House, WA4 6HA Warrington United Kingdom

Location of manufacturing sites

Solvay Interox Limited, Baronet Road, Solvay House, WA4 6HA Warrington United Kingdom


Active substance

Hydrogen peroxide

Name of manufacturer

Solvay Chemicals Finland Oy

Address of manufacturer

YRJONOJANTIE 2, 45910 VOIKKAA Finland

Location of manufacturing sites

Solvay Chemicals Finland Oy, YRJONOJANTIE 2, 45910 VOIKKAA Finland


Active substance

Hydrogen peroxide

Name of manufacturer

Solvay Chemicals GmbH Germany

Address of manufacturer

KOETHENSCHE STRASSE 1-3, 06406 BERNBURG Germany

Location of manufacturing sites

Solvay Chemicals GmbH Germany, KOETHENSCHE STRASSE 1-3, 06406 BERNBURG Germany


Active substance

Hydrogen peroxide

Name of manufacturer

Solvay Chimica Italia SpA Italy

Address of manufacturer

VIA PIAVE, 6 ROSIGNANO SOLVAY, LI 57013 ROSIGNANO Italy

Location of manufacturing sites

Solvay Chimica Italia SpA Italy, VIA PIAVE, 6 ROSIGNANO SOLVAY, LI 57013 ROSIGNANO Italy


Active substance

Hydrogen peroxide

Name of manufacturer

Solvay Chimie SA Belgium

Address of manufacturer

Rue de Ransbeek 310, 1120 Brussels Belgium

Location of manufacturing sites

Solvay Chimie SA Belgium, RUE SOLVAY 39, 5190 BE JEMEPPE-SUR-SAMBRE Belgium

Solvay Chimie SA Belgium, SCHELDELAAN 600 – HAVEN 725, 2040 BE Antwerp Belgium


Active substance

Hydrogen peroxide

Name of manufacturer

Solvay Interox Produtos Peroxidados SA

Address of manufacturer

RUA ENG. CLEMENT DUMOULIN, 2625-106 POVOA DE SANTA IRIA Portugal

Location of manufacturing sites

Solvay Interox Produtos Peroxidados SA, RUA ENG. CLEMENT DUMOULIN, 2625-106 POVOA DE SANTA IRIA Portugal

2.   PRODUCT FAMILY COMPOSITION AND FORMULATION

2.1.   Qualitative and quantitative information on the composition of the family

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Min

Max

Hydrogen peroxide

 

Active Substance

7722-84-1

231-765-0

13,0

49,9

2.2.   Type(s) of formulation

Formulation(s)

SL - Soluble concentrate

AL - Any other liquid

PART II

SECOND INFORMATION LEVEL - META SPC(S)

META SPC 1

1.   META SPC 1 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 1 identifier

Identifier

Meta SPC 1

1.2.   Suffix to the authorisation number

Number

1-1

1.3.   Product type(s)

Product type(s)

PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

2.   META SPC 1 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 1

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Min

Max

Hydrogen peroxide

 

Active Substance

7722-84-1

231-765-0

13,0

13,5

2.2.   Type(s) of formulation of the meta SPC 1

Formulation(s)

AL - Any other liquid

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1

Hazard statements

May intensify fire; oxidiser

Causes serious eye damage.

Precautionary statements

Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. - No smoking.

Keep away from clothing and other combustible materials.

Wear eye protection.

IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.

Immediately call a POISON CENTER or doctor.

In case of fire:Use water to extinguish.

Dispose of contents to in accordance with local/regional/national/international regulation.

Dispose of container to in accordance with local/regional/national/international regulation.

4.   AUTHORISED USE(S) OF THE META SPC 1

4.1.   Use description

Table 1. Use # 1 – Surface disinfection of closed spaces by aerosolised hydrogen peroxide

Product type

PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

Where relevant, an exact description of the authorised use

Not relevant

Target organism(s) (including development stage)

Common name: Bacteria

Development stage:

Common name: Viruses

Development stage:

Common name: Fungi/yeasts

Development stage:

Common name: Bacterial spores

Development stage:

Field(s) of use

Indoor

Indoor, closed spaces.

Industrial/pharmaceutical industry or cosmetics industry, for example clean rooms.

Medical - healthcare facilities, hospitals and emergency vehicles.

Institutional.

Disinfection of non-porous surfaces

Application method(s)

Method: -

Detailed description:

Automated, non-directed aerosolization (e.g. fogging or spraying)

Application rate(s) and frequency

Application Rate: 13% hydrogen peroxide (undiluted product) applied via aerosolization in closed rooms.

Dilution (%):

Number and timing of application:

Frequency - as required by user, for example up to 3 times per day.

Treatment time depends on machine type, size of room or area of surfaces to be disinfected.

Apply at room temperature.

Category(ies) of users

Professional

Pack sizes and packaging material

Pack sizes (L): 0.25, 1, 2.5, 5, 10, 20, 22, 30, 60, 200, 220 and 1000 L

Packaging material: Approved grades of HDPE.

4.1.1.   Use-specific instructions for use

Use an automated loading system.

13% (w/w) hydrogen peroxide (undiluted product) is applied via aerosolization by automated device in a sealed room. Rooms may be dehumidified to achieve higher hydrogen peroxide concentrations on surfaces.

Remove barriers that may hinder aerosolized product from reaching the surfaces to be disinfected.

The disinfected surfaces should be non-porous and cleaned before application of the product. The product is not intended to be used on surfaces that may come into contact with food or feeding stuffs.

The user should carry out a microbiological validation of the disinfection in the rooms to be disinfected (or in a suitable "standard room", if applicable) with the devices to be used, after which a protocol for disinfection of these rooms can be made and used thereafter. Each device or specific installation is systematically validated when it is set up. The optimal operating conditions are validated on site (temperature, hygrometry, product to be used, diffusion time, extraction time, etc.). Besides biological validation chemical validation should be performed.

Efficacy of room disinfection was demonstrated according to norm NF T 72-281 by nebulization of 1 g of hydrogen peroxide per cubic meter of room volume in 22 min followed by 180 min contact time at room temperature.

Volume of disinfected space should be 30 - 150 m3.

Median particle size should be <0.5 μm in aerosols used for disinfection

Prevent entry during disinfection process

4.1.2.   Use-specific risk mitigation measures

Surfaces in the treatment area must be clean and dry prior to application.

Seal the treatment enclosure (e.g. with tape) to ensure that hydrogen peroxide levels outside the enclosure are kept at acceptable health and safety levels.

Ensure all personnel have vacated the treatment enclosure prior to application. Remove all plants, animals, beverages and food. Re-entry is only permitted once the air concentration has dropped below the reference value (1.25 mg/m3). After the application, the room must be ventilated, preferably by mechanical ventilation. The duration of the ventilation period has to be established by measurement with suitable measurement equipment. In case of the room has to be entered when the hydrogen peroxide concentration is still above 1.25 mg/m3 it is only allowed by wearing appropriate PPE including SCBA (Self Contained Breathing Apparatus).

Place warning signs on all entrances to the treatment enclosure.

4.1.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use.

4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use.

4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use.

5.   GENERAL DIRECTIONS FOR USE (1) OF THE META SPC 1

5.1.   Instructions for use

-

5.2.   Risk mitigation measures

The use of eye protection during handling of the product is mandatory.

Wear face shield where splashing is possible.

5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

Particulars of likely direct or indirect adverse effects:

In case of inhalation: Breathing difficulties, cough, pulmonary oedema, nausea, vomiting.

In case of skin contact: Redness, swelling of tissue, skin irritation.

In case of eye contact: Redness, lachrymation, swelling of tissue, severe burns.

In case of ingestion: Nausea, abdominal pain, bloody vomiting, diarrhoea, suffocation, cough, severe shortness of breath, severe burns of the mouth and throat, as well as a danger of perforation of the oesophagus and the stomach. Risk of respiratory disorder.

First aid instructions:

 

IF INHALED: If symptoms occur call a POISON CENTRE or a doctor.

 

IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor.

 

IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. Call 112/ambulance for medical assistance.

 

IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112/ambulance for medical assistance.

Emergency measures to protect environment in case of accident:

Environmental precautions:

Should not be released into the environment. If the product contaminates rivers and lakes or drains inform respective authorities.

Methods and materials for containment and cleaning up:

Dilute with plenty of water. Dam up. Do not mix waste streams during collection. Soak up with inert absorbent material. Keep in properly labelled containers. Keep in suitable, closed containers for disposal. Never return spills in original containers for use.

5.4.   Instructions for safe disposal of the product and its packaging

Do not allow undiluted product to enter the sewer. Do not discharge unused product on the ground, into water courses, into pipes (sink, toilets…) nor down the drains. Only pass on empty containers/packaging for recycling. Disposal of packaging should at all times comply with the waste disposal legislation and any regional local authority requirements.

5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Storage: Hydrogen peroxide should be stored in properly designed bulk storage tanks or in original vented container in upright position away from incompatible products. Use only approved materials of construction for equipment or approved packs. Store in a cool, ventilated area and protect from damage and direct sunlight. Do not store at temperatures above 40 °C. Keep away from combustible materials and sources of ignition and heat.

Shelf-life: 12 months in HDPE packs at ambient temperature.

6.   OTHER INFORMATION

Please be aware of the European reference value of 1.25 mg/m3 for the active substance hydrogen peroxide (CAS No.: 7722-84-1) which was used for the risk assessment for this product.

7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 1

7.1.   Trade name(s), authorisation number and specific composition of each individual product

Trade name(s)

INTEROX SG 12

Market area: EU

Authorisation number

EU-0027468-0001 1-1

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Hydrogen peroxide

 

Active Substance

7722-84-1

231-765-0

13,5

META SPC 2

1.   META SPC 2 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 2 identifier

Identifier

Meta SPC 2

1.2.   Suffix to the authorisation number

Number

1-2

1.3.   Product type(s)

Product type(s)

PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

2.   META SPC 2 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 2

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Min

Max

Hydrogen peroxide

 

Active Substance

7722-84-1

231-765-0

35,0

35,7

2.2.   Type(s) of formulation of the meta SPC 2

Formulation(s)

AL - Any other liquid

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2

Hazard statements

May intensify fire; oxidiser

Harmful if swallowed.

Causes skin irritation.

Causes serious eye damage.

May cause respiratory irritation.

Harmful to aquatic life with long lasting effects.

Precautionary statements

Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. - No smoking.

Keep away from clothing and other combustible materials.

Avoid breathing vapours.

Wash hands thoroughly after handling.

Do no eat, drink or smoke when using this product.

Use only outdoors or in a well-ventilated area.

Avoid release to the environment.

Wear protective gloves.

Wear protective clothing.

Wear eye protection.

Wear face protection.

IF SWALLOWED:Call a POISON CENTER/doctor if you feel unwell.

IF ON SKIN:Wash with plenty of water.

IF INHALED:Remove person to fresh air and keep comfortable for breathing.

IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.

Immediately call a POISON CENTER or doctor.

Rinse mouth.

If skin irritation occurs:Get medical advice.

If skin irritation occurs:Get medical attention.

Take off contaminated clothing.And wash it before reuse.

In case of fire:Use water to extinguish.

Store in a well-ventilated place.Keep container tightly closed.

Store locked up.

Dispose of contents to ...in accordance with all local, regional, national and international regulations..

Dispose of container to in accordance with local/regional/national/international regulation.

4.   AUTHORISED USE(S) OF THE META SPC 2

4.1.   Use description

Table 2. Use # 1 – Surface disinfection of closed spaces by aerosolised hydrogen peroxide

Product type

PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

Where relevant, an exact description of the authorised use

Not relevant

Target organism(s) (including development stage)

Common name: Bacteria

Development stage:

Common name: Fungi/yeasts

Development stage:

Common name: Viruses

Development stage:

Common name: bacterial spores

Development stage:

Field(s) of use

Indoor

Indoor, closed spaces

Industrial – pharmaceutical industry or cosmetics industry, for example clean rooms.

Medical– healthcare facilities, hospitals, emergency vehicles.

Institutional.

Disinfection of non-porous surfaces.

Application method(s)

Method: -

Detailed description:

Automated, non-directed aerosolization (e.g. fogging or spraying)

Application rate(s) and frequency

Application Rate: 35% hydrogen peroxide (undiluted product) applied via aerosolization in closed rooms.

Dilution (%):

Number and timing of application:

Frequency - as required by user, for example up to 3 times per day.

Treatment time depends on machine type, size of room or area of surfaces to be disinfected.

Apply at room temperature.

Category(ies) of users

Professional

Pack sizes and packaging material

Pack sizes (L): 0.25, 1, 2.5, 5, 10, 20, 22, 30, 60, 200, 220 and 1000 L

Packaging material: Approved grades of HDPE.

4.1.1.   Use-specific instructions for use

Use an automated loading system.

35% (w/w) hydrogen peroxide (undiluted product) is applied via aerosolization by automated device in a sealed room. Rooms may be dehumidified to achieve higher hydrogen peroxide concentrations on surfaces.

Remove barriers that may hinder aerosolized product from reaching the surfaces to be disinfected.

The disinfected surfaces should be non-porous and cleaned before application of the product. The product is not intended to be used on surfaces that may come into contact with food or feeding stuffs.

The user should carry out a microbiological validation of the disinfection in the rooms to be disinfected (or in a suitable "standard room", if applicable) with the devices to be used, after which a protocol for disinfection of these rooms can be made and used thereafter. Each device or specific installation is systematically validated when it is set up. The optimal operating conditions are validated on site (temperature, hygrometry, product to be used, diffusion time, extraction time, etc.). Besides biological validation chemical validation should be performed.

Efficacy of room disinfection was demonstrated according to norm NF T 72-281 by nebulization of 1 g of hydrogen peroxide per cubic meter of room volume in 22 min followed by 180 min contact time at room temperature.

Volume of disinfected space should be 30 - 150 m3.

Median particle size should be <0.5 μm in aerosols used for disinfection.

Prevent entry during disinfection process.

4.1.2.   Use-specific risk mitigation measures

Surfaces in the treatment area must be clean and dry prior to application.

Seal the treatment enclosure (e.g. with tape) to ensure that hydrogen peroxide levels outside the enclosure are kept at acceptable health and safety levels.

Ensure all personnel have vacated the treatment enclosure prior to application. Remove all plants, animals, beverages and food. Re-entry is only permitted once the air concentration has dropped below the reference value (1.25 mg/m3). After the application, the room must be ventilated, preferably by mechanical ventilation. The duration of the ventilation period has to be established by measurement with suitable measurement equipment. In case the room has to be entered when the hydrogen peroxide concentration is still above 1.25 mg/m3 it is only allowed by wearing appropriate PPE including SCBA (Self Contained Breathing Apparatus).

Place warning signs on all entrances to the treatment enclosure.

4.1.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use.

4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use.

4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use.

4.2.   Use description

Table 3. Use # 2 – Surface disinfection of enclosures in filling isolators by aerosolised or vaporised hydrogen peroxide (VHP)

Product type

PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

Where relevant, an exact description of the authorised use

Not relevant

Target organism(s) (including development stage)

Common name: Bacteria

Development stage:

Common name: bacterial spores

Development stage:

Common name: Fungi/yeasts

Development stage:

Common name: Viruses

Development stage:

Field(s) of use

Indoor

Indoor.

Industrial – aseptic chambers in aseptic filling applied in pharmaceutical or cosmetics industry.

Disinfection of non-porous surfaces.

Application method(s)

Method: -

Detailed description:

Automated, non-directed aerosolization (e.g. fogging or spraying, flash evaporation)

Application rate(s) and frequency

Application Rate: 35% hydrogen peroxide (undiluted product) applied via flash evaporation or aerosolization in filling isolators.

Dilution (%):

Number and timing of application:

Frequency – as required by user, for example 1 or 2 times per day/week.

Category(ies) of users

Professional

Pack sizes and packaging material

Pack sizes (L): 0.25, 1, 2.5, 5, 10, 20, 22, 30, 60, 200, 220 and 1000 L.

Packaging material: Approved grades of HDPE

4.2.1.   Use-specific instructions for use

Use an automated loading system.

35% (w/w) hydrogen peroxide (undiluted product) is applied via flash evaporation or aerosolization by automated device connected to an filling isolator. Filling isolators may be dehumidified to achieve higher hydrogen peroxide concentrations on surfaces.

The disinfected surfaces should be non-porous and cleaned before application of the product. The product is not intended to be used on surfaces that may come into contact with food or feeding stuffs.

The user should carry out a microbiological validation of the disinfection in the enclosures to be disinfected with the devices to be used, after which a protocol for disinfection of these enclosures can be made and used thereafter. Each device or specific installation is systematically validated when it is set up. The optimal operating conditions are validated on site (temperature, hygrometry, product to be used, diffusion time, extraction time, etc.). Besides biological validation chemical validation should be performed.

Efficacy of use against bacterial spores was demonstrated by flash evaporation of hydrogen peroxide at a rate of 0.35 g/m3/min for 51 min (18 g hydrogen peroxide / m3 / treatment).

Volume of disinfected enclosure should be 15 - 150 m3.

Median particle size should be <0.5 μm in aerosols used for disinfection.

Prevent entry during disinfection process.

4.2.2.   Use-specific risk mitigation measures

Surfaces in the treatment area must be clean and dry prior to application.

Seal the treatment enclosure (e.g. with tape) to ensure that hydrogen peroxide levels outside the enclosure are kept at acceptable health and safety levels.

Ensure all personnel have vacated the treatment enclosure prior to application. Remove all plants, animals, beverages and food. Re-entry is only permitted once the air concentration has dropped below the reference value (1.25 mg/m3).

After the application, the room must be ventilated, preferably by mechanical ventilation. The duration of the ventilation period has to be established by measurement with suitable measurement equipment. In case the room has to be entered when the hydrogen peroxide concentration is still above 1.25 mg/m3 it is only allowed by wearing appropriate PPE including SCBA (Self Contained Breathing Apparatus).

Place warning signs on all entrances to the treatment enclosure.

4.2.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use.

4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use.

4.2.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use.

5.   GENERAL DIRECTIONS FOR USE (2) OF THE META SPC 2

5.1.   Instructions for use

-

5.2.   Risk mitigation measures

The use of eye protection during handling of the product is mandatory.

Wear face shield where splashing is possible.

5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

Particulars of likely direct or indirect adverse effects:

In case of inhalation: Breathing difficulties, cough, pulmonary oedema, nausea, vomiting.

In case of skin contact: Redness, swelling of tissue, skin irritation.

In case of eye contact: Redness, lachrymation, swelling of tissue, severe burns.

In case of ingestion: Nausea, abdominal pain, bloody vomiting, diarrhoea, suffocation, cough, severe shortness of breath, severe burns of the mouth and throat, as well as a danger of perforation of the oesophagus and the stomach. Risk of respiratory disorder.

First aid instructions:

 

IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. If symptoms: Call 112/ambulance for medical assistance. If no symptoms: Call a POISON CENTRE or a doctor.

 

IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor.

 

IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. Call 112/ambulance for medical assistance.

 

IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112/ambulance for medical assistance.

Emergency measures to protect environment in case of accident:

Environmental precautions:

Should not be released into the environment. If the product contaminates rivers and lakes or drains inform respective authorities.

Methods and materials for containment and cleaning up:

Dilute with plenty of water. Dam up. Do not mix waste streams during collection. Soak up with inert absorbent material. Keep in properly labelled containers. Keep in suitable, closed containers for disposal. Never return spills in original containers for re-use.

5.4.   Instructions for safe disposal of the product and its packaging

Do not allow undiluted product to enter the sewer. Do not discharge unused product on the ground, into water courses, into pipes (sink, toilets…) nor down the drains. Only pass on empty containers/packaging for recycling. Disposal of packaging should at all times comply with the waste disposal legislation and any regional local authority requirements.

5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Storage: Hydrogen peroxide should be stored in properly designed bulk storage tanks or in original vented container in upright position away from incompatible products. Use only approved materials of construction for equipment or approved packs. Store in a cool, ventilated area and protect from damage and direct sunlight. Do not store at temperatures above 40 °C. Keep away from combustible materials and sources of ignition and heat.

Shelf-life: 12 months in HDPE packs at ambient temperature.

6.   OTHER INFORMATION

Please be aware of the European reference value of 1.25 mg/m3 for the active substance hydrogen peroxide (CAS No.: 7722-84-1) which was used for the risk assessment for this product.

7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 2

7.1.   Trade name(s), authorisation number and specific composition of each individual product

Trade name(s)

INTEROX SG 35

Market area: EU

Authorisation number

EU-0027468-0002 1-2

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Hydrogen peroxide

 

Active Substance

7722-84-1

231-765-0

35,7

7.2.   Trade name(s), authorisation number and specific composition of each individual product

Trade name(s)

INTEROX SG 35 PLUS

Market area: EU

Authorisation number

EU-0027468-0003 1-2

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Hydrogen peroxide

 

Active Substance

7722-84-1

231-765-0

35,7

META SPC 3

1.   META SPC 3 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 3 identifier

Identifier

Meta SPC 3

1.2.   Suffix to the authorisation number

Number

1-3

1.3.   Product type(s)

Product type(s)

PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

2.   META SPC 3 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 3

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Min

Max

Hydrogen peroxide

 

Active Substance

7722-84-1

231-765-0

49,0

49,9

2.2.   Type(s) of formulation of the meta SPC 3

Formulation(s)

AL - Any other liquid

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 3

Hazard statements

May intensify fire; oxidiser

Harmful if swallowed.

Causes severe skin burns and eye damage.

May cause respiratory irritation.

Harmful to aquatic life with long lasting effects.

Precautionary statements

Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. - No smoking.

Keep away from clothing and other combustible materials.

Do not breathe vapours.

Wash hands thoroughly after handling.

Do no eat, drink or smoke when using this product.

Use only outdoors or in a well-ventilated area.

Avoid release to the environment.

Wear protective gloves.

Wear protective clothing.

Wear eye protection.

Wear face protection.

IF SWALLOWED:Call a POISON CENTER/doctor if you feel unwell.

IF SWALLOWED:Rinse mouth.Do NOT induce vomiting.

IF ON SKIN (or hair):Take off immediately all contaminated clothing.Rinse skin with water.

IF INHALED:Remove person to fresh air and keep comfortable for breathing.

IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.

Immediately call a POISON CENTER or doctor.

Wash contaminated clothing before reuse.

In case of fire:Use water to extinguish.

Store in a well-ventilated place.Keep container tightly closed.

Store locked up.

Dispose of contents to ...in accordance with all local, regional, national and international regulations.

Dispose of container to in accordance with local/regional/national/international regulation.

4.   AUTHORISED USE(S) OF THE META SPC 3

4.1.   Use description

Table 4. Use # 1 – Surface disinfection of closed spaces by aerosolised hydrogen peroxide

Product type

PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

Where relevant, an exact description of the authorised use

Not relevant

Target organism(s) (including development stage)

Common name: Bacteria

Development stage:

Common name: Fungi/yeasts

Development stage:

Common name: Viruses

Development stage:

Common name: Bacterial Spores

Development stage:

Field(s) of use

Indoor

Indoor, closed spaces.

Industrial – pharmaceutical industry or cosmetics industry, for example clean rooms.

Medical– healthcare facilities, hospitals, emergency vehicles.

Institutional.

Disinfection of non-porous surfaces.

Application method(s)

Method: -

Detailed description:

Automated, non-directed aerosolization (e.g. fogging or spraying).

Application rate(s) and frequency

Application Rate: 49% hydrogen peroxide (undiluted product) applied via aerosolization in closed rooms.

Dilution (%):

Number and timing of application:

Frequency - as required by user, for example up to 3 times per day.

Treatment time depends on machine type, size of room or area of surfaces to be disinfected.

Apply at room temperature.

Category(ies) of users

Professional

Pack sizes and packaging material

Pack sizes (L): 0.25, 1, 2.5, 5, 10, 20, 22, 30, 60, 200, 220 and 1000 L

Packaging material: Approved grades of HDPE.

4.1.1.   Use-specific instructions for use

Use an automated loading system.

49% (w/w) hydrogen peroxide (undiluted product) is applied via aerosolization by automated device in a sealed room. Rooms may be dehumidified to achieve higher hydrogen peroxide concentrations on surfaces.

Remove barriers that may hinder aerosolized product from reaching the surfaces to be disinfected.

The disinfected surfaces should be non-porous and cleaned before application of the product. The product is not intended to be used on surfaces that may come into contact with food or feeding stuffs.

The user should carry out a microbiological validation of the disinfection in the rooms to be disinfected (or in a suitable "standard room", if applicable) with the devices to be used, after which a protocol for disinfection of these rooms can be made and used thereafter. Each device or specific installation is systematically validated when it is set up. The optimal operating conditions are validated on site (temperature, hygrometry, product to be used, diffusion time, extraction time, etc.). Besides biological validation chemical validation should be performed.

Efficacy of room disinfection was demonstrated according to norm NF T 72-281by nebulization of 1 g of hydrogen peroxide per cubic meter of room volume in 22 min followed by 180 min contact time at room temperature.

Volume of disinfected space should be 30 - 150 m3.

Median particle size should be <0.5 μm in aerosols used for disinfection.

Prevent entry during disinfection process.

4.1.2.   Use-specific risk mitigation measures

Surfaces in the treatment area must be clean and dry prior to application.

Seal the treatment enclosure (e.g. with tape) to ensure that hydrogen peroxide levels outside the enclosure are kept at acceptable health and safety levels.

Ensure all personnel have vacated the treatment enclosure prior to application. Remove all plants, animals, beverages and food. Re-entry is only permitted once the air concentration has dropped below the reference value (1.25 mg/m3). After the application, the room must be ventilated, preferably by mechanical ventilation. The duration of the ventilation period has to be established by measurement with suitable measurement equipment. In case the room has to be entered when the hydrogen peroxide concentration is still above 1.25 mg/m3 it is only allowed by wearing appropriate PPE including SCBA (Self Contained Breathing Apparatus).

Place warning signs on all entrances to the treatment enclosure.

4.1.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use.

4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use.

4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use.

4.2.   Use description

Table 5. Use # 2 – Surface disinfection of enclosures in filling isolators by aerosolised or vaporised hydrogen peroxide (VHP)

Product type

PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

Where relevant, an exact description of the authorised use

Not relevant

Target organism(s) (including development stage)

Common name: Bacteria

Development stage:

Common name: bacterial spores

Development stage:

Common name: Fungi/yeasts

Development stage:

Common name: Viruses

Development stage:

Field(s) of use

Indoor

Indoor.

Industrial – aseptic chambers in aseptic filling applied in pharmaceutical or cosmetics industry.

Disinfection of non-porous surfaces.

Application method(s)

Method: -

Detailed description:

Automated, non-directed aerosolization (e.g. fogging or spraying, flash evaporation)

Application rate(s) and frequency

Application Rate: 49% hydrogen peroxide (undiluted product) applied via flash evaporation or aerosolization in filling isolators.

Dilution (%):

Number and timing of application:

Frequency – as required by user, for example 1 or 2 times per day/week.

Category(ies) of users

Professional

Pack sizes and packaging material

Pack sizes (L): 0.25, 1, 2.5, 5, 10, 20, 22, 30, 60, 200, 220 and 1000 L.

Packaging material: Approved grades of HDPE.

4.2.1.   Use-specific instructions for use

Use an automated loading system.

49% (w/w) hydrogen peroxide (undiluted product) is applied via flash evaporation or aerosolization by automated device connected to an filling isolator. Filling isolators may be dehumidified to achieve higher hydrogen peroxide concentrations on surfaces.

The disinfected surfaces should be non-porous and cleaned before application of the product. The product is not intended to be used on surfaces that may come into contact with food or feeding stuffs.

The user should carry out a microbiological validation of the disinfection in the enclosures to be disinfected with the devices to be used, after which a protocol for disinfection of these enclosures can be made and used thereafter. Each device or specific installation is systematically validated when it is set up. The optimal operating conditions are validated on site (temperature, hygrometry, product to be used, diffusion time, extraction time, etc.). Besides biological validation chemical validation should be performed.

Efficacy of use against bacterial spores was demonstrated by flash evaporation of hydrogen peroxide at a rate of 0.35 g/m3/min for 51 min (18 g hydrogen peroxide / m3 / treatment).

Volume of disinfected enclosure should be 15 - 150 m3.

Median particle size should be <0.5 μm in aerosols used for disinfection.

Prevent entry during disinfection process.

4.2.2.   Use-specific risk mitigation measures

Surfaces in the treatment area must be clean and dry prior to application.

Seal the treatment enclosure (e.g. with tape) to ensure that hydrogen peroxide levels outside the enclosure are kept at acceptable health and safety levels.

Ensure all personnel have vacated the treatment enclosure prior to application. Remove all plants, animals, beverages and food. Re-entry is only permitted once the air concentration has dropped below the reference value (1.25 mg/m3).

After the application, the room must be ventilated, preferably by mechanical ventilation. The duration of the ventilation period has to be established by measurement with suitable measurement equipment. In case the room has to be entered when the hydrogen peroxide concentration is still above 1.25 mg/m3 it is only allowed by wearing appropriate PPE including SCBA (Self Contained Breathing Apparatus).

Place warning signs on all entrances to the treatment enclosure.

4.2.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use.

4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use.

4.2.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use.

5.   GENERAL DIRECTIONS FOR USE (3) OF THE META SPC 3

5.1.   Instructions for use

-

5.2.   Risk mitigation measures

The use of eye protection during handling of the product is mandatory.

Wear face shield where splashing is possible.

5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

Particulars of likely direct or indirect adverse effects:

In case of inhalation: Breathing difficulties, cough, pulmonary oedema, nausea, vomiting.

In case of skin contact: Redness, swelling of tissue, skin irritation.

In case of eye contact: Redness, lachrymation, swelling of tissue, severe burns.

In case of ingestion: Nausea, abdominal pain, bloody vomiting, diarrhoea, suffocation, cough, severe shortness of breath, severe burns of the mouth and throat, as well as a danger of perforation of the oesophagus and the stomach. Risk of respiratory disorder.

First aid instructions:

 

IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. If symptoms: Call 112/ambulance for medical assistance. If no symptoms: Call a POISON CENTRE or a doctor.

 

IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor.

 

IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. Call 112/ambulance for medical assistance.

 

IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112/ambulance for medical assistance.

Emergency measures to protect environment in case of accident:

Environmental precautions:

Should not be released into the environment. If the product contaminates rivers and lakes or drains inform respective authorities.

Methods and materials for containment and cleaning up:

Dilute with plenty of water. Dam up. Do not mix waste streams during collection. Soak up with inert absorbent material. Keep in properly labelled containers. Keep in suitable, closed containers for disposal. Never return spills in original containers for re-use.

5.4.   Instructions for safe disposal of the product and its packaging

Do not allow undiluted product to enter the sewer. Do not discharge unused product on the ground, into water courses, into pipes (sink, toilets…) nor down the drains. Only pass on empty containers/packaging for recycling. Disposal of packaging should at all times comply with the waste disposal legislation and any regional local authority requirements.

5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Storage: Hydrogen peroxide should be stored in properly designed bulk storage tanks or in original vented container in upright position away from incompatible products. Use only approved materials of construction for equipment or approved packs. Store in a cool, ventilated area and protect from damage and direct sunlight. Do not store at temperatures above 40 °C. Keep away from combustible materials and sources of ignition and heat.

Shelf-life: 12 months in HDPE packs at ambient temperature.

6.   OTHER INFORMATION

Please be aware of the European reference value of 1.25 mg/m3 for the active substance hydrogen peroxide (CAS No.: 7722-84-1) which was used for the risk assessment for this product.

7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 3

7.1.   Trade name(s), authorisation number and specific composition of each individual product

Trade name(s)

Interox SG 50

Market area: EU

Authorisation number

EU-0027468-0004 1-3

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Hydrogen peroxide

 

Active Substance

7722-84-1

231-765-0

49,9

7.2.   Trade name(s), authorisation number and specific composition of each individual product

Trade name(s)

INTEROX SG 50 PLUS

Market area: EU

Authorisation number

EU-0027468-0005 1-3

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Hydrogen peroxide

 

Active Substance

7722-84-1

231-765-0

49,9

META SPC 4

1.   META SPC 4 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 4 identifier

Identifier

Meta SPC 4

1.2.   Suffix to the authorisation number

Number

1-4

1.3.   Product type(s)

Product type(s)

PT04 - Food and feed area (Disinfectants)

2.   META SPC 4 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 4

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Min

Max

Hydrogen peroxide

 

Active Substance

7722-84-1

231-765-0

25,0

25,7

2.2.   Type(s) of formulation of the meta SPC 4

Formulation(s)

AL - Any other liquid

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 4

Hazard statements

May intensify fire; oxidiser

Harmful if swallowed.

Causes serious eye damage.

Harmful to aquatic life with long lasting effects.

Precautionary statements

Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. - No smoking.

Keep away from clothing and other combustible materials.

Wash hands thoroughly after handling.

Do no eat, drink or smoke when using this product.

Avoid release to the environment.

Wear eye protection.

IF SWALLOWED:Call a POISON CENTER/doctor if you feel unwell.

IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.

Immediately call a POISON CENTER/doctor.

Rinse mouth.

In case of fire:Use water to extinguish.

Store in a well-ventilated place.Keep container tightly closed.

Store locked up.

Dispose of contents to ….in accordance with all local, regional, national and international regulations..

Dispose of container to in accordance with local/regional/national/international regulation.

4.   AUTHORISED USE(S) OF THE META SPC 4

4.1.   Use description

Table 6. Use # 1 – Disinfection of polyethylene terephthalate food packages by vaporised hydrogen peroxide (VHP)

Product type

PT04 - Food and feed area (Disinfectants)

Where relevant, an exact description of the authorised use

Not relevant

Target organism(s) (including development stage)

Common name: Bacterial Spores

Development stage:

Field(s) of use

Indoor

Industrial use - food and feed area.

Disinfection of food package material.

Application method(s)

Method: -

Detailed description:

Automated vaporization in aseptic filling machines

Application rate(s) and frequency

Application Rate: Undiluted product (25 % w/w hydrogen peroxide) vaporized 400 g/h/packaging machine.

Dilution (%):

Number and timing of application:

Number and timing of applications as required by user. Machines typically operate up to 120 hours per week.

Category(ies) of users

Professional

Pack sizes and packaging material

HDPE packaging: 0.25, 1, 2.5, 5, 10, 20, 22, 30, 60, 200, 220 and 1000 L (IBC).

Approved grades of HDPE.

4.1.1.   Use-specific instructions for use

Use an automated loading system.

Use undiluted product (25 % w/w hydrogen peroxide) to disinfect polyethylene terephthalate food packages used in aseptic packaging in food industry..

Follow machine operating instructions for disinfection period, extraction of hydrogen peroxide and re-entry. Prevent entry during disinfection process. Efficacy was demonstrated with a packaging machine running at 12 480 bottles per hour with a production consumption rate of 400 g/h.

Disinfection performance of each packaging machine should be validated using biological and chemical indicators.

After sterilisation, blow-dry the packaging with hot sterile air.

4.1.2.   Use-specific risk mitigation measures

During operation, ensure adequate ventilation along the machines (LEV) and in the industrial halls (technical ventilation).

During manual maintenance tasks, ensure adequate ventilation inside the machine (LEV) before opening the doors of the aseptic area.

1

The product shall only be transferred in closed pipes after mixing and loading. Open product and waste water flows are not allowed.

2.

Workplace release measurements with suitable measurement equipment shall be performed upon implementation of the aseptic packaging plant, at regular intervals (annual intervals recommended) and after any change in relevant boundary conditions. The national regulations for workplace measurements have to be followed.

3.

In case of maintenance of the aseptic packaging plant (e.g. manual cleaning, technical incidents or repair) appropriate PPE (respiratory protective equipment, chemical protective gloves, chemical protective coverall (at least type 6), eye protection) is required. The type of RPE and the filter type (code letter, colour) are to be specified by the authorisation holder within the product information. Glove material to be specified by the authorisation holder within the product information.

Use only in closed aseptic packaging machines with no emission to water and negligible emission to air. Hydrogen peroxide emission to air should be controlled by the machine e.g. with catalytic treatment or through a gas scrubber.

4.1.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use.

4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use.

4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use.

5.   GENERAL DIRECTIONS FOR USE (4) OF THE META SPC 4

5.1.   Instructions for use

-

5.2.   Risk mitigation measures

The use of eye protection during handling of the product is mandatory.

Wear face shield where splashing is possible.

5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

Particulars of likely direct or indirect adverse effects:

In case of inhalation: Breathing difficulties, cough, pulmonary oedema, nausea, vomiting.

In case of skin contact: Redness, swelling of tissue, skin irritation.

In case of eye contact: Redness, lachrymation, swelling of tissue, severe burns.

In case of ingestion: Nausea, abdominal pain, bloody vomiting, diarrhoea, suffocation, cough, severe shortness of breath, severe burns of the mouth and throat, as well as a danger of perforation of the oesophagus and the stomach. Risk of respiratory disorder.

First aid instructions:

 

IF INHALED: If symptoms occur call a POISON CENTRE or a doctor.

 

IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor.

 

IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. Call 112/ambulance for medical assistance.

 

IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112/ambulance for medical assistance.

Emergency measures to protect environment in case of accident:

Environmental precautions:

Should not be released into the environment. If the product contaminates rivers and lakes or drains inform respective authorities.

Methods and materials for containment and cleaning up:

Dilute with plenty of water. Dam up. Do not mix waste streams during collection. Soak up with inert absorbent material. Keep in properly labelled containers. Keep in suitable, closed containers for disposal. Never return spills in original containers for re-use.

5.4.   Instructions for safe disposal of the product and its packaging

Do not allow undiluted product to enter the sewer. Do not discharge unused product on the ground, into water courses, into pipes (sink, toilets…) nor down the drains. Only pass on empty containers/packaging for recycling. Disposal of packaging should at all times comply with the waste disposal legislation and any regional local authority requirements.

5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Storage: Hydrogen peroxide should be stored in properly designed bulk storage tanks or in original vented container in upright position away from incompatible products. Use only approved materials of construction for equipment or approved packs. Store in a cool, ventilated area and protect from damage and direct sunlight. Do not store at temperatures above 40°C. Keep away from combustible materials and sources of ignition and heat.

Shelf-life: 12 months in HDPE packs at ambient temperature.

6.   OTHER INFORMATION

Please be aware of the European reference value of 1.25 mg/m3 for the active substance hydrogen peroxide (CAS No.: 7722-84-1) which was used for the risk assessment for this product.

7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 4

7.1.   Trade name(s), authorisation number and specific composition of each individual product

Trade name(s)

INTEROX AG Spray 25S

Market area: EU

Authorisation number

EU-0027468-0006 1-4

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Hydrogen peroxide

 

Active Substance

7722-84-1

231-765-0

25,7

META SPC 5

1.   META SPC 5 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 5 identifier

Identifier

Meta SPC 5

1.2.   Suffix to the authorisation number

Number

1-5

1.3.   Product type(s)

Product type(s)

PT04 - Food and feed area (Disinfectants)

2.   META SPC 5 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 5

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Min

Max

Hydrogen peroxide

 

Active Substance

7722-84-1

231-765-0

35,0

35,7

2.2.   Type(s) of formulation of the meta SPC 5

Formulation(s)

AL - Any other liquid

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 5

Hazard statements

May intensify fire; oxidiser

Harmful if swallowed.

Causes skin irritation.

Causes serious eye damage.

May cause respiratory irritation.

Harmful to aquatic life with long lasting effects.

Precautionary statements

Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. - No smoking.

Keep away from clothing and other combustible materials.

Avoid breathing vapours.

Wash hands thoroughly after handling.

Do no eat, drink or smoke when using this product.

Use only outdoors or in a well-ventilated area.

Avoid release to the environment.

Wear protective gloves.

Wear protective clothing.

Wear eye protection.

Wear face protection.

IF SWALLOWED:Call a POISON CENTER/doctor if you feel unwell.

IF ON SKIN:Wash with plenty of water.

IF INHALED:Remove person to fresh air and keep comfortable for breathing.

IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.

Immediately call a POISON CENTER or doctor.

Rinse mouth.

If skin irritation occurs:Get medical advice.

If skin irritation occurs:Get medical attention.

Take off contaminated clothing.And wash it before reuse.

In case of fire:Use water to extinguish.

Store in a well-ventilated place.Keep container tightly closed.

Store locked up.

Dispose of contents to ….in accordance with all local, regional, national and international regulations..

Dispose of container to in accordance with local/regional/national/international regulation.

4.   AUTHORISED USE(S) OF THE META SPC 5

4.1.   Use description

Table 7. Use # 1 – Disinfection of food packaging material (aseptic packaging) by immersion or aerosolised or vaporised hydrogen peroxide (VHP)

Product type

PT04 - Food and feed area (Disinfectants)

Where relevant, an exact description of the authorised use

Not relevant

Target organism(s) (including development stage)

Common name: Bacterial Spores

Development stage:

Field(s) of use

Indoor

Industrial use - food and feed area.

Disinfection of food package material.

Application method(s)

Method: -

Detailed description:

Automated immersion of packaging material into bath of heated product in aseptic filling machine.

Automated vaporisation or aerosolisation of product in sealed area in aseptic filling machine.

Application rate(s) and frequency

Application Rate: Undiluted product (35 % w/w hydrogen peroxide) is used. Product consumption in vapour and aerosol applications 0.1 – 1 mL per second per packaging line while the machine is operating.

Dilution (%):

Number and timing of application:

Number and timing of applications as required by user.

Machines typically operate up to 120 hours per week.

Category(ies) of users

Professional

Pack sizes and packaging material

HDPE packaging: 0.25, 1, 2.5, 5, 10, 20, 22, 30, 60, 200, 220 and 1000 L (IBC).

Approved grades of HDPE.

4.1.1.   Use-specific instructions for use

Use an automated loading system.

Immersion: immerse clean packaging material in undiluted product according to packaging machine operating instruction Disinfection efficacy is determined by immersion time and temperature and packaging material.

Efficacy was demonstrated by immersion of carton food packages in 80 °C bath for 2.5 s.

If concentration of hydrogen peroxide in the bath drops to less than 32% during operation, replace solution with fresh product.

Vaporization: vaporize and apply undiluted product to clean packaging material according to packaging machine operating instructions. Product vaporized at 100-250 °C. Efficacy was demonstrated with polyethylene terephthalate packages flushed with 100 °C air containing 1.1% (w/w) of product for 5.5 s.

After sterilisation, blow-dry the packaging with hot sterile air.

Suitable packaging materials included paperboard, polyethylene terephthalate, polystyrene and aluminium.

Disinfection performance of each packaging machine should be validated using biological and chemical indicators.

Follow machine operating instructions for disinfection period, extraction of hydrogen peroxide and re-entry. Prevent entry during disinfection process.

4.1.2.   Use-specific risk mitigation measures

During operation, ensure adequate ventilation along the machines (LEV) and in the industrial halls (technical ventilation).

During manual maintenance tasks, ensure adequate ventilation inside the machine (LEV) before opening the doors of the aseptic area.

1.

The product shall only be transferred in closed pipes after mixing and loading. Open product and waste water flows are not allowed.

2.

Workplace release measurements with suitable measurement equipment shall be performed upon implementation of the aseptic packaging plant, at regular intervals (annual intervals recommended) and after any change in relevant boundary conditions. The national regulations for workplace measurements have to be followed.

3.

In case of maintenance of the aseptic packaging plant (e.g. manual cleaning, technical incidents or repair) appropriate PPE (respiratory protective equipment, chemical protective gloves, chemical protective coverall (at least type 6), eye protection) is required. The type of RPE and the filter type (code letter, colour) are to be specified by the authorisation holder within the product information. Glove material to be specified by the authorisation holder within the product information

Aerosolised or vaporised application should be use only in closed aseptic packaging machines with no emission to water and negligible emission to air. Hydrogen peroxide emission to air should be controlled by the machine e.g. with catalytic treatment or through a gas scrubber.

4.1.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use.

4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use.

4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use.

4.2.   Use description

Table 8. Use # 2 – Disinfection of closed areas in aseptic packaging machines by aerosolised and vaporised hydrogen peroxide (VHP)

Product type

PT04 - Food and feed area (Disinfectants)

Where relevant, an exact description of the authorised use

Not relevant

Target organism(s) (including development stage)

Common name: Bacterial Spores

Development stage:

Field(s) of use

Indoor

Industrial use - food and feed area.

Disinfection of non-porous surfaces.

Application method(s)

Method: -

Detailed description:

Automated vaporisation or aerosolization in closed areas in aseptic filling machines.

Application rate(s) and frequency

Application Rate: Undiluted product (35 % w/w hydrogen peroxide) is used. 100 – 800 mL product consumed per machine in one disinfection cycle.

Dilution (%):

Number and timing of application:

Frequency – as required by user, typically once every 24 hours.

Category(ies) of users

Professional

Pack sizes and packaging material

HDPE packaging: 0.25, 1, 2.5, 5, 10, 20, 22, 30, 60, 200, 220 and 1000 L (IBC).

Approved grades of HDPE.

4.2.1.   Use-specific instructions for use

Use an automated loading system.

Automated disinfection of closed areas in aseptic filling machines.

Flash evaporation 130-250 °C or aerosolization (room temperature) of undiluted product using automated equipment integrated to the packaging machine. From 100 to 800 mL product required for one disinfection cycle. Minimum contact time 7 minutes starting from beginning of application.

Disinfection performance of each packaging machine should be validated using biological and chemical indicators.

Follow machine operating instructions for disinfection period, volume of disinfectant extraction of hydrogen peroxide and re-entry. Prevent entry during disinfection process.

4.2.2.   Use-specific risk mitigation measures

During operation, ensure adequate ventilation along the machines (LEV) and in the industrial halls (technical ventilation).

During manual maintenance tasks, ensure adequate ventilation inside the machine (LEV) before opening the doors of the aseptic area.

1.

The product shall only be transferred in closed pipes after mixing and loading. Open product and waste water flows are not allowed.

2.

Workplace release measurements with suitable measurement equipment shall be performed upon implementation of the aseptic packaging plant, at regular intervals (annual intervals recommended) and after any change in relevant boundary conditions. The national regulations for workplace measurements have to be followed.

3.

In case of maintenance of the aseptic packaging plant (e.g. manual cleaning, technical incidents or repair) appropriate PPE (respiratory protective equipment, chemical protective gloves, chemical protective coverall (at least type 6), eye protection) is required. The type of RPE and the filter type (code letter, colour) are to be specified by the authorisation holder within the product information. Glove material to be specified by the authorisation holder within the product information.

Use only in closed aseptic packaging machines with no emission to water and negligible emission to air. Hydrogen peroxide emission to air should be controlled by the machine e.g. with catalytic treatment or through a gas scrubber.

4.2.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use.

4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use.

4.2.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use.

5.   GENERAL DIRECTIONS FOR USE (5) OF THE META SPC 5

5.1.   Instructions for use

-

5.2.   Risk mitigation measures

The use of eye protection during handling of the product is mandatory.

Wear face shield where splashing is possible.

5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

Particulars of likely direct or indirect adverse effects:

In case of inhalation: Breathing difficulties, cough, pulmonary oedema, nausea, vomiting.

In case of skin contact: Redness, swelling of tissue, skin irritation.

In case of eye contact: Redness, lachrymation, swelling of tissue, severe burns.

In case of ingestion: Nausea, abdominal pain, bloody vomiting, diarrhoea, suffocation, cough, severe shortness of breath, severe burns of the mouth and throat, as well as a danger of perforation of the oesophagus and the stomach. Risk of respiratory disorder.

First aid instructions:

 

IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. If symptoms: Call 112/ambulance for medical assistance. If no symptoms: Call a POISON CENTRE or a doctor.

 

IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor.

 

IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. Call 112/ambulance for medical assistance.

 

IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112/ambulance for medical assistance.

Emergency measures to protect environment in case of accident:

Environmental precautions:

Should not be released into the environment. If the product contaminates rivers and lakes or drains inform respective authorities.

Methods and materials for containment and cleaning up:

Dilute with plenty of water. Dam up. Do not mix waste streams during collection. Soak up with inert absorbent material. Keep in properly labelled containers. Keep in suitable, closed containers for disposal. Never return spills in original containers for re-use.

5.4.   Instructions for safe disposal of the product and its packaging

Do not allow undiluted product to enter the sewer. Do not discharge unused product on the ground, into water courses, into pipes (sink, toilets…) nor down the drains. Only pass on empty containers/packaging for recycling. Disposal of packaging should at all times comply with the waste disposal legislation and any regional local authority requirements.

5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Storage: Hydrogen peroxide should be stored in properly designed bulk storage tanks or in original vented container in upright position away from incompatible products. Use only approved materials of construction for equipment or approved packs. Store in a cool, ventilated area and protect from damage and direct sunlight. Do not store at temperatures above 40°C. Keep away from combustible materials and sources of ignition and heat.

Shelf-life: 12 months in HDPE packs at ambient temperature.

6.   OTHER INFORMATION

Please be aware of the European reference value of 1.25 mg/m3 for the active substance hydrogen peroxide (CAS No.: 7722-84-1) which was used for the risk assessment for this product.

7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 5

7.1.   Trade name(s), authorisation number and specific composition of each individual product

Trade name(s)

INTEROX AG Spray 35

Market area: EU

Authorisation number

EU-0027468-0007 1-5

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Hydrogen peroxide

 

Active Substance

7722-84-1

231-765-0

35,7

7.2.   Trade name(s), authorisation number and specific composition of each individual product

Trade name(s)

INTEROX AG Spray 35S

Market area: EU

Authorisation number

EU-0027468-0008 1-5

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Hydrogen peroxide

 

Active Substance

7722-84-1

231-765-0

35,7

7.3.   Trade name(s), authorisation number and specific composition of each individual product

Trade name(s)

INTEROX AG Bath 35S

Market area: EU

Authorisation number

EU-0027468-0009 1-5

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Hydrogen peroxide

 

Active Substance

7722-84-1

231-765-0

35,7

7.4.   Trade name(s), authorisation number and specific composition of each individual product

Trade name(s)

INTEROX AG Bath 35

Market area: EU

Authorisation number

EU-0027468-0010 1-5

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Hydrogen peroxide

 

Active Substance

7722-84-1

231-765-0

35,7

7.5.   Trade name(s), authorisation number and specific composition of each individual product

Trade name(s)

INTEROX AG Dual 35

Market area: EU

Authorisation number

EU-0027468-0011 1-5

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Hydrogen peroxide

 

Active Substance

7722-84-1

231-765-0

35,7

META SPC 6

1.   META SPC 6 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 6 identifier

Identifier

Meta SPC 6

1.2.   Suffix to the authorisation number

Number

1-6

1.3.   Product type(s)

Product type(s)

PT04 - Food and feed area (Disinfectants)

2.   META SPC 6 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 6

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Min

Max

Hydrogen peroxide

 

Active Substance

7722-84-1

231-765-0

35,0

35,7

2.2.   Type(s) of formulation of the meta SPC 6

Formulation(s)

SL - Soluble concentrate

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 6

Hazard statements

May intensify fire; oxidiser

Harmful if swallowed.

Causes skin irritation.

Causes serious eye damage.

May cause respiratory irritation.

Harmful to aquatic life with long lasting effects.

Precautionary statements

Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. - No smoking.

Keep away from clothing and other combustible materials.

Avoid breathing vapours.

Wash hands thoroughly after handling.

Do no eat, drink or smoke when using this product.

Use only outdoors or in a well-ventilated area.

Avoid release to the environment.

Wear protective gloves.

Wear protective clothing.

Wear eye protection.

Wear face protection.

IF SWALLOWED:Call a POISON CENTER/doctor if you feel unwell.

IF ON SKIN:Wash with plenty of water.

IF INHALED:Remove person to fresh air and keep comfortable for breathing.

IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.

Immediately call a POISON CENTER or doctor.

Rinse mouth.

If skin irritation occurs:Get medical advice.

If skin irritation occurs:Get medical attention.

Take off contaminated clothing.And wash it before reuse.

In case of fire:Use water to extinguish.

Store in a well-ventilated place.Keep container tightly closed.

Store locked up.

Dispose of contents to ….in accordance with all local, regional, national and international regulations..

Dispose of container to in accordance with local/regional/national/international regulation.

4.   AUTHORISED USE(S) OF THE META SPC 6

4.1.   Use description

Table 9. Use # 1 – Disinfection of distribution and storage systems for drinking water

Product type

PT04 - Food and feed area (Disinfectants)

Where relevant, an exact description of the authorised use

Not relevant

Target organism(s) (including development stage)

Common name: Bacteria

Development stage:

Common name: Fungi/yeasts

Development stage:

Common name: Viruses

Development stage:

Common name: Bacterial Spores

Development stage:

Field(s) of use

Indoor

Industrial use - drinking water systems for human and animals drinking water.

Disinfection of non-porous surfaces.

Application method(s)

Method: -

Detailed description:

Flooding of pipes

Automated spraying (CIP)

Application rate(s) and frequency

Application Rate: Use concentration 13% w/w hydrogen peroxide.

Dilution (%):

Number and timing of application:

Apply at room temperature.

Frequency: once per week.

Use following installation, maintenance or cleaning.

Category(ies) of users

Professional

Pack sizes and packaging material

HDPE packaging: 0.25, 1, 2.5, 5, 10, 20, 22, 30, 60, 200, 220 and 1000 L (IBC).

Approved grades of HDPE.

4.1.1.   Use-specific instructions for use

Use an automated loading system.

Dilute the product to reach the needed hydrogen peroxide concentration stated below.

Effective hydrogen peroxide (w/w) concentration and contact time:

 

Bactericidal – 13%, 10 min

 

Yeasticidal and fungicidal – 13%, 15 min

 

Sporicidal – 13 %, 60 min

 

Virucidal – 13%, 30 min

 

All claimed microbes - 13%, 60 min

Each product label should give information on how the dilution should be made, e.g. to reach 13% (w/w) hydrogen peroxide concentration:

A product with 35 % hydrogen peroxide concentration: The product should be diluted to 39% w/v (390 g or 340 mL of product, add water up to 1L).

Apply diluted product at room temperature on pre-cleaned surfaces. Add as aqueous solution to pipes as needed for flooding. Spray application to tanks until run-off. Surface need to be wet with disinfectant for the allocated contact time.

4.1.2.   Use-specific risk mitigation measures

CIP and automated spraying:

The processes must be fully automated and enclosed with no exposure in the case of tanks or piping systems.

The use is limited to distribution and storage systems with volume ≤ 15 000 L. Rinse well with potable water.

4.1.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use.

4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use.

4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use.

4.2.   Use description

Table 10. Use # 2 – Surface disinfection in food and feed processing by liquid application

Product type

PT04 - Food and feed area (Disinfectants)

Where relevant, an exact description of the authorised use

Disinfection of equipment, containers, consumption utensils, surfaces or pipework associated with the production, transport, storage or consumption of food or feed for humans and animals.

Target organism(s) (including development stage)

Common name: Bacteria

Development stage:

Common name: Fungi/yeasts

Development stage:

Common name: Viruses

Development stage:

Common name: Bacterial Spores

Development stage:

Field(s) of use

Indoor

Industrial use - food & feed area.

Disinfection of non-porous surfaces.

Application method(s)

Method: -

Detailed description:

Automated spraying on surfaces

Cleaning-in-Place (CIP)

Immersion of equipment and utensils

Application rate(s) and frequency

Application Rate: Use concentration 13% w/w hydrogen peroxide.

Dilution (%):

Number and timing of application:

CIP (cleaning-in-place): volume of diluted product needed to fill the system to be disinfected

Automated spraying: 50 – 100 mL diluted product/m2

Immersion: make solution and dip items

As required by user - up to 1 or 2 times per day, often once per week.

Apply at room temperature.

Category(ies) of users

Professional

Pack sizes and packaging material

HDPE packaging: 0.25, 1, 2.5, 5, 10, 20, 22, 30, 60, 200, 220 and 1000 L (IBC).

Approved grades of HDPE.

4.2.1.   Use-specific instructions for use

Disinfection of pre-cleaned, non-porous surfaces such as tables, floors, walls, machinery, equipment and utensils in food & feed areas in production, transport, storage or preparation and handling. CIP (cleaning in place) disinfection (terminal disinfection after cleaning) – pipes, tanks, mixer, other machine which comes into contact with food. Soaking of pre-cleaned items – dishes, cutlery, equipment, small machinery, machine items, crates, boxes.

Use an automated loading system for CIP and automated spraying.

Dilute the product to reach the needed hydrogen peroxide concentration stated below.

Effective hydrogen peroxide (w/w) concentration and contact time:

 

Bactericidal, yeasticidal, fungicidal – 13%, 15 min

 

Sporicidal – 13 %, 60 min

 

Virucidal – 13%, 30 min

 

All claimed microbes - 13%, 60 min

Each product label should give information on how the dilution should be made, e.g. to reach 13% (w/w) hydrogen peroxide concentration:

A product with 35% hydrogen peroxide concentration: The product should be diluted to 39% w/v (390 g or 340 mL of product, add water up to 1L).

Apply at room temperature.

Precleaning of surfaces required before using disinfectants.

Dosing

—   Automated spraying 50 – 100 mL/m2

Surface need to be wet with disinfectant for the allocated contact time. Rinse well with potable water and allow to drain or dry with hot air.

4.2.2.   Use-specific risk mitigation measures

CIP:

The processes must be fully automated and enclosed with no exposure in the case of tanks or piping systems.

Automated spraying:

In the case of automated spraying of surfaces such as conveyors or other fixed installations workers must leave the room before processing.

Disinfection can only be processed after the end of a shift with all workers having left the room. The process must be started from outside the room. Warning notices indicating that entry is denied and temporary barriers must be placed on all entries.

Air concentrations must be monitored to ensure that no leakage occurs during operations. For re-entry, the undercut of AECinhalation of 1.25 mg/m3 shall be ensured with technical and organisational measures (e.g. sensor, defined ventilation period).

Immersion:

The use of eye protection during handling of the product is mandatory.

Wear protective chemical resistant gloves during product handling phase (glove material to be specified by the authorisation holder within the product information).

A protective coverall (at least type 6, EN 13034) shall be worn in loading.

For stationary processes, a local exhaust ventilation (LEV) with a capture efficiency of at least 85% shall be specified.

If no LEV, use respiratory protective equipment (RPE) providing a protection factor of 20 in loading and 5 for immersion.

After use, immersion baths must be emptied or covered to prevent further evaporation.

The waste water from breweries should not be discharged direct to surface water after simple on-site treatment. The waste water from breweries should be discharged to the sewer connected to the sewage treatment plant (STP).

4.2.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use.

4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use.

4.2.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use.

5.   GENERAL DIRECTIONS FOR USE (6) OF THE META SPC 6

5.1.   Instructions for use

-

5.2.   Risk mitigation measures

The use of eye protection during handling of the product is mandatory.

Wear face shield where splashing is possible.

Ensure adequate ventilation during the application.

5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

Particulars of likely direct or indirect adverse effects:

In case of inhalation: Breathing difficulties, cough, pulmonary oedema, nausea, vomiting.

In case of skin contact: Redness, swelling of tissue, skin irritation.

In case of eye contact: Redness, lachrymation, swelling of tissue, severe burns.

In case of ingestion: Nausea, abdominal pain, bloody vomiting, diarrhoea, suffocation, cough, severe shortness of breath, severe burns of the mouth and throat, as well as a danger of perforation of the oesophagus and the stomach. Risk of respiratory disorder.

First aid instructions:

 

IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. If symptoms: Call 112/ambulance for medical assistance. If no symptoms: Call a POISON CENTRE or a doctor.

 

IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor.

 

IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. Call 112/ambulance for medical assistance.

 

IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112/ambulance for medical assistance.

Emergency measures to protect environment in case of accident:

Environmental precautions:

Should not be released into the environment. If the product contaminates rivers and lakes or drains inform respective authorities.

Methods and materials for containment and cleaning up:

Dilute with plenty of water. Dam up. Do not mix waste streams during collection. Soak up with inert absorbent material. Keep in properly labelled containers. Keep in suitable, closed containers for disposal. Never return spills in original containers for re-use.

5.4.   Instructions for safe disposal of the product and its packaging

Do not allow undiluted product to enter the sewer. Do not discharge unused product on the ground, into water courses, into pipes (sink, toilets…) nor down the drains. Only pass on empty containers/packaging for recycling. Disposal of packaging should at all times comply with the waste disposal legislation and any regional local authority requirements.

5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Storage: Hydrogen peroxide should be stored in properly designed bulk storage tanks or in original vented container in upright position away from incompatible products. Use only approved materials of construction for equipment or approved packs. Store in a cool, ventilated area and protect from damage and direct sunlight. Do not store at temperatures above 40°C. Keep away from combustible materials and sources of ignition and heat.

Shelf-life: 12 months in HDPE packs at ambient temperature.

6.   OTHER INFORMATION

Please be aware of the European reference value of 1.25 mg/m3 for the active substance hydrogen peroxide (CAS No.: 7722-84-1) which was used for the risk assessment for this product.

7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 6

7.1.   Trade name(s), authorisation number and specific composition of each individual product

Trade name(s)

INTEROX FCC 35

Market area: EU

Authorisation number

EU-0027468-0012 1-6

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Hydrogen peroxide

 

Active Substance

7722-84-1

231-765-0

35,7

META SPC 7

1.   META SPC 7 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 7 identifier

Identifier

Meta SPC 7

1.2.   Suffix to the authorisation number

Number

1-7

1.3.   Product type(s)

Product type(s)

PT04 - Food and feed area (Disinfectants)

2.   META SPC 7 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 7

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Min

Max

Hydrogen peroxide

 

Active Substance

7722-84-1

231-765-0

49,0

49,9

2.2.   Type(s) of formulation of the meta SPC 7

Formulation(s)

SL - Soluble concentrate

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 7

Hazard statements

May intensify fire; oxidiser

Harmful if swallowed.

Causes severe skin burns and eye damage.

May cause respiratory irritation.

Harmful to aquatic life with long lasting effects.

Precautionary statements

Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. - No smoking.

Keep away from clothing and other combustible materials.

Do not breathe vapours.

Wash hands thoroughly after handling.

Do no eat, drink or smoke when using this product.

Use only outdoors or in a well-ventilated area.

Avoid release to the environment.

Wear protective gloves.

Wear protective clothing.

Wear eye protection.

Wear face protection.

IF SWALLOWED:Call a POISON CENTER/doctor if you feel unwell.

IF SWALLOWED:Rinse mouth.Do NOT induce vomiting.

IF ON SKIN (or hair):Take off immediately all contaminated clothing.Rinse skin with water.

IF INHALED:Remove person to fresh air and keep comfortable for breathing.

IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.

Immediately call a POISON CENTER or doctor.

Wash contaminated clothing before reuse.

In case of fire:Use water to extinguish.

Store in a well-ventilated place.Keep container tightly closed.

Store locked up.

Dispose of contents to ….in accordance with all local, regional, national and international regulations..

Dispose of container to in accordance with local/regional/national/international regulation.

4.   AUTHORISED USE(S) OF THE META SPC 7

4.1.   Use description

Table 11. Use # 1 – Disinfection of distribution and storage systems for drinking water

Product type

PT04 - Food and feed area (Disinfectants)

Where relevant, an exact description of the authorised use

Not relevant

Target organism(s) (including development stage)

Common name: Bacteria

Development stage:

Common name: Fungi/yeasts

Development stage:

Common name: Viruses

Development stage:

Common name: Bacterial Spores

Development stage:

Field(s) of use

Indoor

Industrial use - drinking water systems for human and animals drinking water.

Disinfection of non-porous surfaces.

Application method(s)

Method: -

Detailed description:

Flooding of pipes

Automated spraying (CIP)

Application rate(s) and frequency

Application Rate: Use concentration 13% w/w hydrogen peroxide.

Dilution (%):

Number and timing of application:

Apply at room temperature.

Frequency: once per week.

Use following installation, maintenance or cleaning.

Category(ies) of users

Professional

Pack sizes and packaging material

HDPE packaging: 0.25, 1, 2.5, 5, 10, 20, 22, 30, 60, 200, 220 and 1000 L (IBC).

Approved grades of HDPE.

4.1.1.   Use-specific instructions for use

Use an automated loading system.

Dilute the product to reach the needed hydrogen peroxide concentration stated below.

Effective hydrogen peroxide (w/w) concentration and contact time:

 

Bactericidal – 13%, 10 min

 

Yeasticidal and fungicidal – 13%, 15 min

 

Sporicidal – 13 %, 60 min

 

Virucidal – 13%, 30 min

 

All claimed microbes - 13%, 60 min

Each product label should give information on how the dilution should be made, e.g. to reach 13% (w/w) hydrogen peroxide concentration:

A product with 50% hydrogen peroxide concentration: The product should be diluted to 28% w/v (280 g or 230 mL of product, add water up to 1L).

Apply diluted product at room temperature on pre-cleaned surfaces. Add as aqueous solution to pipes as needed for flooding. Spray application to tanks until run-off. Surface need to be wet with disinfectant for the allocated contact time.

4.1.2.   Use-specific risk mitigation measures

CIP and automated spraying:

The processes must be fully automated and enclosed with no exposure in the case of tanks or piping systems.

The use is limited to distribution and storage systems with volume ≤ 15 000 L. Rinse well with potable water.

4.1.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use.

4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use.

4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use.

4.2.   Use description

Table 12. Use # 2 – Surface disinfection in food and feed processing by liquid application

Product type

PT04 - Food and feed area (Disinfectants)

Where relevant, an exact description of the authorised use

Disinfection of equipment, containers, consumption utensils, surfaces or pipework associated with the production, transport, storage or consumption of food or feed for humans and animals.

Target organism(s) (including development stage)

Common name: Bacteria

Development stage:

Common name: Fungi/yeasts

Development stage:

Common name: Viruses

Development stage:

Common name: Bacterial Spores

Development stage:

Field(s) of use

Indoor

Industrial use - food & feed area.

Disinfection of non-porous surfaces.

Application method(s)

Method: -

Detailed description:

Automated spraying on surfaces

Cleaning-in-Place (CIP)

Immersion of equipment and utensils

Application rate(s) and frequency

Application Rate: Use concentration 13% w/w hydrogen peroxide.

Dilution (%):

Number and timing of application:

CIP (cleaning-in-place): volume of diluted product needed to fill the system to be disinfected

Automated spraying: 50 – 100 mL diluted product/m2

Immersion: make solution and dip items

As required by user - up to 1 or 2 times per day, often once per week.

Apply at room temperature.

Category(ies) of users

Professional

Pack sizes and packaging material

HDPE packaging: 0.25, 1, 2.5, 5, 10, 20, 22, 30, 60, 200, 220 and 1000 L (IBC).

Approved grades of HDPE.

4.2.1.   Use-specific instructions for use

Disinfection of pre-cleaned, non-porous surfaces such as tables, floors, walls, machinery, equipment and utensils in food & feed areas in production, transport, storage or preparation and handling. CIP (cleaning in place) disinfection (terminal disinfection after cleaning) – pipes, tanks, mixer, other machine which comes into contact with food. Soaking of pre-cleaned items – dishes, cutlery, equipment, small machinery, machine items, crates, boxes.

Use an automated loading system for CIP and automated spraying.

Dilute the product to reach the needed hydrogen peroxide concentration stated below.

Effective hydrogen peroxide (w/w) concentration and contact time:

 

Bactericidal, yeasticidal, fungicidal – 13%, 15 min

 

Sporicidal – 13%, 60 min

 

Virucidal – 13%, 30 min

 

All claimed microbes - 13%, 60 min

Each product label should give information on how the dilution should be made, e.g. to reach 13% (w/w) hydrogen peroxide concentration:

A product with 50% hydrogen peroxide concentration: The product should be diluted to 28% w/v (280 g or 230 mL of product, add water up to 1L).

Apply at room temperature.

Precleaning of surfaces required before using disinfectants.

Dosing

—   Automated spraying 50 – 100 mL/m2

Surface need to be wet with disinfectant for the allocated contact time.

Rinse well with potable water and allow to drain or dry with hot air.

4.2.2.   Use-specific risk mitigation measures

CIP:

The processes must be fully automated and enclosed with no exposure in the case of tanks or piping systems.

Automated spraying:

In the case of automated spraying of surfaces such as conveyors or other fixed installations workers must leave the room before processing.

Disinfection can only be processed after the end of a shift with all workers having left the room. The process must be started from outside the room. Warning notices indicating that entry is denied and temporary barriers must be placed on all entries.

Air concentrations must be monitored to ensure that no leakage occurs during operations and levels are safe before entering the area. For re-entry, the undercut of AECinhalation of 1.25 mg/m3 shall be ensured with technical and organisational measures (e.g. sensor, defined ventilation period).

Immersion:

The use of eye protection during handling of the product is mandatory.

Wear protective chemical resistant gloves during product handling phase (glove material to be specified by the authorisation holder within the product information).

A protective coverall (at least type 6, EN 13034) shall be worn in loading.

For stationary processes, a local exhaust ventilation (LEV) with a capture efficiency of at least 85% shall be specified.

If no LEV, use respiratory protective equipment (RPE) providing a protection factor of 20 in loading and 5 for immersion.

After use, immersion baths must be emptied or covered to prevent further evaporation.

The waste water from breweries should not be discharged direct to surface water after simple on-site treatment. The waste water from breweries should be discharged to the sewer connected to the sewage treatment plant (STP).

4.2.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use.

4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use.

4.2.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use.

5.   GENERAL DIRECTIONS FOR USE (7) OF THE META SPC 7

5.1.   Instructions for use

-

5.2.   Risk mitigation measures

The use of eye protection during handling of the product is mandatory.

Wear face shield where splashing is possible.

Ensure adequate ventilation during the application.

5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

Particulars of likely direct or indirect adverse effects:

In case of inhalation: Breathing difficulties, cough, pulmonary oedema, nausea, vomiting.

In case of skin contact: Redness, swelling of tissue, skin irritation.

In case of eye contact: Redness, lachrymation, swelling of tissue, severe burns.

In case of ingestion: Nausea, abdominal pain, bloody vomiting, diarrhoea, suffocation, cough, severe shortness of breath, severe burns of the mouth and throat, as well as a danger of perforation of the oesophagus and the stomach. Risk of respiratory disorder.

First aid instructions:

 

IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. If symptoms: Call 112/ambulance for medical assistance. If no symptoms: Call a POISON CENTRE or a doctor.

 

IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor.

 

IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. Call 112/ambulance for medical assistance.

 

IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112/ambulance for medical assistance.

Emergency measures to protect environment in case of accident:

Environmental precautions:

Should not be released into the environment. If the product contaminates rivers and lakes or drains inform respective authorities.

Methods and materials for containment and cleaning up:

Dilute with plenty of water. Dam up. Do not mix waste streams during collection. Soak up with inert absorbent material. Keep in properly labelled containers. Keep in suitable, closed containers for disposal. Never return spills in original containers for re-use.

5.4.   Instructions for safe disposal of the product and its packaging

Do not allow undiluted product to enter the sewer. Do not discharge unused product on the ground, into water courses, into pipes (sink, toilets…) nor down the drains. Only pass on empty containers/packaging for recycling. Disposal of packaging should at all times comply with the waste disposal legislation and any regional local authority requirements.

5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Storage: Hydrogen peroxide should be stored in properly designed bulk storage tanks or in original vented container in upright position away from incompatible products. Use only approved materials of construction for equipment or approved packs. Store in a cool, ventilated area and protect from damage and direct sunlight. Do not store at temperatures above 40°C. Keep away from combustible materials and sources of ignition and heat.

Shelf-life: 12 months in HDPE packs at ambient temperature.

6.   OTHER INFORMATION

Please be aware of the European reference value of 1.25 mg/m3 for the active substance hydrogen peroxide (CAS No.: 7722-84-1) which was used for the risk assessment for this product.

7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 7

7.1.   Trade name(s), authorisation number and specific composition of each individual product

Trade name(s)

INTEROX FCC 50

Market area: EU

Authorisation number

EU-0027468-0013 1-7

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Hydrogen peroxide

 

Active Substance

7722-84-1

231-765-0

49,9

META SPC 8

1.   META SPC 8 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 8 identifier

Identifier

Meta SPC 8

1.2.   Suffix to the authorisation number

Number

1-8

1.3.   Product type(s)

Product type(s)

PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

PT03 - Veterinary hygiene (Disinfectants)

2.   META SPC 8 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 8

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Min

Max

Hydrogen peroxide

 

Active Substance

7722-84-1

231-765-0

35,0

35,7

2.2.   Type(s) of formulation of the meta SPC 8

Formulation(s)

SL - Soluble concentrate

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 8

Hazard statements

May intensify fire; oxidiser

Harmful if swallowed.

Causes skin irritation.

Causes serious eye damage.

May cause respiratory irritation.

Harmful to aquatic life with long lasting effects.

Precautionary statements

Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. - No smoking.

Keep away from clothing and other combustible materials.

Avoid breathing vapours.

Avoid breathing spray.

Wash hands thoroughly after handling.

Do no eat, drink or smoke when using this product.

Use only outdoors or in a well-ventilated area.

Avoid release to the environment.

Wear protective gloves.

Wear protective clothing.

Wear eye protection.

Wear face protection.

IF SWALLOWED:Call a POISON CENTER/doctor if you feel unwell.

IF ON SKIN:Wash with plenty of water.

IF INHALED:Remove person to fresh air and keep comfortable for breathing.

IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.

Immediately call a POISON CENTER or doctor.

Rinse mouth.

If skin irritation occurs:Get medical advice.

If skin irritation occurs:Get medical attention.

Take off contaminated clothing.And wash it before reuse.

In case of fire:Use water to extinguish.

Store in a well-ventilated place.Keep container tightly closed.

Store locked up.

Dispose of contents to ….in accordance with all local, regional, national and international regulations..

Dispose of container to in accordance with local/regional/national/international regulation.

4.   AUTHORISED USE(S) OF THE META SPC 8

4.1.   Use description

Table 13. Use # 1 – Surface disinfection by liquid application in industrial and institutional areas

Product type

PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

Where relevant, an exact description of the authorised use

Not relevant

Target organism(s) (including development stage)

Common name: Bacteria

Development stage:

Common name: Fungi/yeasts

Development stage:

Common name: Viruses

Development stage:

Common name: Bacterial spores

Development stage:

Field(s) of use

Indoor

Industrial or institutional use.

Disinfection of non-porous surfaces.

Application method(s)

Method: -

Detailed description:

Automated spraying on surfaces

Cleaning-in-Place (CIP)

Immersion of equipment and utensils

Application rate(s) and frequency

Application Rate: Use concentration 13% w/w hydrogen peroxide.

Dilution (%):

Number and timing of application:

CIP (cleaning-in-place): volume of diluted product needed to fill the disinfected system

Automated spraying: 50 -100 mL diluted product/m2

Immersion: make solution and dip items

Frequency - as required by the user.

Apply at room temperature.

Category(ies) of users

Professional

Pack sizes and packaging material

HDPE packaging: 0.25, 1, 2.5, 5, 10, 20, 22, 30, 60, 200, 220 and 1000 L (IBC).

Approved grades of HDPE.

4.1.1.   Use-specific instructions for use

Use an automated loading system for CIP and automated spraying.

Dilute the product to reach the needed hydrogen peroxide concentration stated below.

Effective hydrogen peroxide concentration (w/w) and contact time:

 

Bactericidal - 13 %, 10 min

 

Sporicidal – 13%, 60 min

 

Yeasticidal and fungicidal – 13%, 15 min

 

Virucidal – 13%, 30 min

 

All claimed microbes - 13%, 60 min

Each product label should give information on how the dilution should be made, e.g. to reach 13% (w/w) hydrogen peroxide concentration:

A product with 35% hydrogen peroxide concentration: The product should be diluted to 39% w/v (390 g or 340 mL of product, add water up to 1L).

Precleaning of surfaces required before using disinfectants.

Automated spraying of diluted product 50 -100 mL /m2 on non-porous surfaces. Surface needs to stay wet for the allocated contact time.

Immerse instruments in diluted product for the allocated contact time. Allow to drain and dry.

4.1.2.   Use-specific risk mitigation measures

CIP:

The processes must be fully automated and enclosed with no exposure in the case of tanks or piping systems.

Automated spraying:

In the case of automated spraying of surfaces such as conveyors or other fixed installations workers must leave the room before processing.

Disinfection can only be processed after the end of a shift with all workers having left the room. The process must be started from outside the room. Warning notices indicating that entry is denied and temporary barriers must be placed on all entries.

Air concentrations must be monitored to ensure that no leakage occurs during operations. For re-entry, the undercut of AECinhalation of 1.25 mg/m3 shall be ensured with technical and organisational measures (e.g. sensor, defined ventilation period).

Immersion:

The use of eye protection during handling of the product is mandatory.

Wear protective chemical resistant gloves during product handling phase (glove material to be specified by the authorisation holder within the product information).

A protective coverall (at least type 6, EN 13034) shall be worn in loading.

For stationary processes, a local exhaust ventilation (LEV) with a capture efficiency of at least 85% shall be specified.

If no LEV, use respiratory protective equipment (RPE) providing a protection factor of 20 in loading and 5 for immersion.

After use, immersion baths must be emptied or covered to prevent further evaporation.

4.1.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use.

4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use.

4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use.

4.2.   Use description

Table 14. Use # 2 – Disinfection of surfaces associated with animal housing by spraying

Product type

PT03 - Veterinary hygiene (Disinfectants)

Where relevant, an exact description of the authorised use

Not relevant

Target organism(s) (including development stage)

Common name: Bacteria

Development stage:

Common name: Fungi/yeasts

Development stage:

Common name: Viruses

Development stage:

Field(s) of use

Indoor

Disinfection of non-porous materials and surfaces associated with the housing of animals.

Application method(s)

Method: -

Detailed description:

Spraying with automated or manual equipment

Application rate(s) and frequency

Application Rate: Use concentration 9.5-13 % w/w hydrogen peroxide.

Dilution (%):

Number and timing of application:

Spraying: 50 -100 mL diluted product/m2.

Frequency depends on life-cycle of animals - as required by user.

Category(ies) of users

Professional

Pack sizes and packaging material

HDPE packaging: 0.25, 1, 2.5, 5, 10, 20, 22, 30, 60, 200, 220 and 1000 L (IBC).

Approved grades of HDPE.

4.2.1.   Use-specific instructions for use

Dilute the product to reach the needed hydrogen peroxide concentration stated below.

Effective hydrogen peroxide concentration (w/w) and contact time:

 

Bactericidal and yeasticidal - 9.5%, 30 min

 

Fungicidal – 13%, 60 min

 

Virucidal – 13%, 30 min

 

All claimed microbes - 13%, 60 min

Each product label should give information on how the dilution should be made, e.g. to reach 13% (w/w) hydrogen peroxide concentration:

A product with 35% hydrogen peroxide concentration: The product should be diluted to 39% w/v (390 g or 340 mL of product, add water up to 1L).

Remove animals from spaces to be disinfected. Precleaning of surfaces required before using disinfectants.

Spray diluted product 50 -100 mL /m2 on non-porous surfaces. Surface needs to stay wet for the allocated contact time. Allow to drain and dry.

4.2.2.   Use-specific risk mitigation measures

Automated spraying systems:

During the operation worker must leave the area and access must be denied by appropriate barriers or locked doors. After operation efficient ventilation (10 ACH) must be used to reach a safe level. During this period access must also be denied. Air concentrations must be monitored to ensure that no leakage occurs during operations. For re-entry, the undercut of AECinhalation of 1.25 mg/m3 shall be ensured with technical and organisational measures (e.g. sensor, defined ventilation period).

For manual spraying:

The use of eye protection during handling of the product is mandatory.

Wear protective chemical resistant gloves during product handling phase (glove material to be specified by the authorisation holder within the product information).

A protective coverall (at least type 6, EN 13034) shall be worn.

Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory. At least a powered air purifying respirator with helmet/hood/mask (TH1/TM1), or a half/full mask with combination filter gas/P2 is required (filter type (code letter, colour) to be specified by the authorisation holder within the product information).

Only operators wearing the specified RPE should be present while spraying or fumigating.

The operator must walk backward towards the exit while spraying the surfaces so always walking away from sprayed areas.

Efficient ventilation (10 ACH) must be used during spraying and access must be denied by appropriate barriers and notices. Also after operation efficient ventilation (10 ACH) must be used to reach a safe level. During this period access must also be denied. Air concentrations must be monitored to ensure that no leakage occurs during operations. For re-entry, the undercut of AECinhalation of 1.25 mg/m3 shall be ensured with technical and organisational measures (e.g. sensor, defined ventilation period).

No secondary exposure is expected because of rapid decomposition of hydrogen peroxide.

4.2.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use.

4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use.

4.2.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use.

5.   GENERAL DIRECTIONS FOR USE (8) OF THE META SPC 8

5.1.   Instructions for use

-

5.2.   Risk mitigation measures

The use of eye protection during handling of the product is mandatory.

Wear face shield where splashing is possible.

Ensure adequate ventilation during the application.

5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

Particulars of likely direct or indirect adverse effects:

In case of inhalation: Breathing difficulties, cough, pulmonary oedema, nausea, vomiting.

In case of skin contact: Redness, swelling of tissue, skin irritation.

In case of eye contact: Redness, lachrymation, swelling of tissue, severe burns.

In case of ingestion: Nausea, abdominal pain, bloody vomiting, diarrhoea, suffocation, cough, severe shortness of breath, severe burns of the mouth and throat, as well as a danger of perforation of the oesophagus and the stomach. Risk of respiratory disorder.

First aid instructions:

 

IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. If symptoms: Call 112/ambulance for medical assistance. If no symptoms: Call a POISON CENTRE or a doctor.

 

IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor.

 

IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. Call 112/ambulance for medical assistance.

 

IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112/ambulance for medical assistance.

Emergency measures to protect environment in case of accident:

Environmental precautions:

Should not be released into the environment. If the product contaminates rivers and lakes or drains inform respective authorities.

Methods and materials for containment and cleaning up:

Dilute with plenty of water. Dam up. Do not mix waste streams during collection. Soak up with inert absorbent material. Keep in properly labelled containers. Keep in suitable, closed containers for disposal. Never return spills in original containers for re-use.

5.4.   Instructions for safe disposal of the product and its packaging

Do not allow undiluted product to enter the sewer. Do not discharge unused product on the ground, into water courses, into pipes (sink, toilets…) nor down the drains. Only pass on empty containers/packaging for recycling. Disposal of packaging should at all times comply with the waste disposal legislation and any regional local authority requirements.

5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Storage: Hydrogen peroxide should be stored in properly designed bulk storage tanks or in original vented container in upright position away from incompatible products. Use only approved materials of construction for equipment or approved packs. Store in a cool, ventilated area and protect from damage and direct sunlight. Do not store at temperatures above 40°C. Keep away from combustible materials and sources of ignition and heat.

Shelf-life: 12 months in HDPE packs at ambient temperature.

6.   OTHER INFORMATION

Please be aware of the European reference value of 1.25 mg/m3 for the active substance hydrogen peroxide (CAS No.: 7722-84-1) which was used for the risk assessment for this product.

7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 8

7.1.   Trade name(s), authorisation number and specific composition of each individual product

Trade name(s)

INTEROX BT 35

Market area: EU

Authorisation number

EU-0027468-0014 1-8

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Hydrogen peroxide

 

Active Substance

7722-84-1

231-765-0

35,7

META SPC 9

1.   META SPC 9 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 9 identifier

Identifier

Meta SPC 9

1.2.   Suffix to the authorisation number

Number

1-9

1.3.   Product type(s)

Product type(s)

PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

PT03 - Veterinary hygiene (Disinfectants)

2.   META SPC 9 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 9

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Min

Max

Hydrogen peroxide

 

Active Substance

7722-84-1

231-765-0

49,0

49,9

2.2.   Type(s) of formulation of the meta SPC 9

Formulation(s)

SL - Soluble concentrate

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 9

Hazard statements

May intensify fire; oxidiser

Harmful if swallowed.

Causes severe skin burns and eye damage.

May cause respiratory irritation.

Harmful to aquatic life with long lasting effects.

Precautionary statements

Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. - No smoking.

Keep away from clothing and other combustible materials.

Do not breathe vapours.

Do not breathe spray.

Wash hands thoroughly after handling.

Do no eat, drink or smoke when using this product.

Use only outdoors or in a well-ventilated area.

Avoid release to the environment.

Wear protective gloves.

Wear protective clothing.

Wear eye protection.

Wear face protection.

IF SWALLOWED:Call a POISON CENTER/doctor if you feel unwell.

IF SWALLOWED:Rinse mouth.Do NOT induce vomiting.

IF ON SKIN (or hair):Take off immediately all contaminated clothing.Rinse skin with water.

IF INHALED:Remove person to fresh air and keep comfortable for breathing.

IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.

Immediately call a POISON CENTER or doctor.

Wash contaminated clothing before reuse.

In case of fire:Use water to extinguish.

Store in a well-ventilated place.Keep container tightly closed.

Store locked up.

Dispose of contents to ….in accordance with all local, regional, national and international regulations..

Dispose of container to in accordance with local/regional/national/international regulation.

4.   AUTHORISED USE(S) OF THE META SPC 9

4.1.   Use description

Table 15. Use # 1 – Surface disinfection by liquid application in industrial and institutional areas

Product type

PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

Where relevant, an exact description of the authorised use

Not relevant

Target organism(s) (including development stage)

Common name: Bacteria

Development stage:

Common name: Fungi/yeasts

Development stage:

Common name: Viruses

Development stage:

Common name: Bacterial spores

Development stage:

Field(s) of use

Indoor

Industrial or institutional use.

Disinfection of non-porous surfaces.

Application method(s)

Method: -

Detailed description:

Automated spraying on surfaces

Cleaning-in-Place (CIP)

Immersion of equipment and utensils

Application rate(s) and frequency

Application Rate: Use concentration 13% w/w hydrogen peroxide.

Dilution (%):

Number and timing of application:

CIP (cleaning-in-place): volume of diluted product needed to fill the disinfected system

Automated spraying: 50 -100 mL diluted product/m2

Immersion: make solution and dip items

Frequency - as required by the user.

Apply at room temperature.

Category(ies) of users

Professional

Pack sizes and packaging material

HDPE packaging: 0.25, 1, 2.5, 5, 10, 20, 22, 30, 60, 200, 220 and 1000 L (IBC).

Approved grades of HDPE.

4.1.1.   Use-specific instructions for use

Use an automated loading system for CIP and automated spraying.

Dilute the product to reach the needed hydrogen peroxide concentration stated below.

Effective hydrogen peroxide concentration (w/w) and contact time:

 

Bactericidal - 13%, 10 min

 

Sporicidal – 13%, 60 min

 

Yeasticidal and fungicidal – 13%, 15 min

 

Virucidal – 13%, 30 min

 

All claimed microbes - 13%, 60 min

Each product label should give information on how the dilution should be made, e.g. to reach 13% (w/w) hydrogen peroxide concentration:

A product with 50% hydrogen peroxide concentration: The product should be diluted to 28% w/v (280 g or 230 mL of product, add water up to 1 L).

Precleaning of surfaces required before using disinfectants.

Automated spraying of diluted product 50 -100 mL /m2 on non-porous surfaces. Surface needs to stay wet for the allocated contact time.

Immerse instruments in diluted product for the allocated contact time. Allow to drain and dry.

4.1.2.   Use-specific risk mitigation measures

CIP:

The processes must be fully automated and enclosed with no exposure in the case of tanks or piping systems.

Automated spraying:

In the case of automated spraying of surfaces such as conveyors or other fixed installations workers must leave the room before processing.

Disinfection can only be processed after the end of a shift with all workers having left the room. The process must be started from outside the room. Warning notices indicating that entry is denied and temporary barriers must be placed on all entries.

Air concentrations must be monitored to ensure that no leakage occurs during operations. For re-entry, the undercut of AECinhalation of 1.25 mg/m3 shall be ensured with technical and organisational measures (e.g. sensor, defined ventilation period).

Immersion:

The use of eye protection during handling of the product is mandatory.

Wear protective chemical resistant gloves during product handling phase (glove material to be specified by the authorisation holder within the product information).

A protective coverall (at least type 6, EN 13034) shall be worn in loading.

For stationary processes, a local exhaust ventilation (LEV) with a capture efficiency of at least 85% shall be specified.

If no LEV, use respiratory protective equipment (RPE) providing a protection factor of 20 in loading and 5 for immersion.

After use, immersion baths must be emptied or covered to prevent further evaporation.

4.1.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use

4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use.

4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use.

4.2.   Use description

Table 16. Use # 2 – Disinfection of surfaces associated with animal housing by spraying

Product type

PT03 - Veterinary hygiene (Disinfectants)

Where relevant, an exact description of the authorised use

Not relevant.

Target organism(s) (including development stage)

Common name: Bacteria

Development stage:

Common name: Fungi/yeasts

Development stage:

Common name: Viruses

Development stage:

Field(s) of use

Indoor

Disinfection of non-porous materials and surfaces associated with the housing of animals.

Application method(s)

Method: -

Detailed description:

Spraying with automated or manual equipment

Application rate(s) and frequency

Application Rate: Use concentration 9.5-13 % w/w hydrogen peroxide.

Dilution (%):

Number and timing of application:

Spraying: 50 -100 mL diluted product/m2

Frequency depends on life-cycle of animals - as required by user.

Category(ies) of users

Professional

Pack sizes and packaging material

HDPE packaging: 0.25, 1, 2.5, 5, 10, 20, 22, 30, 60, 200, 220 and 1000 L (IBC).

Approved grades of HDPE.

4.2.1.   Use-specific instructions for use

Dilute the product to reach the needed hydrogen peroxide concentration stated below.

Effective hydrogen peroxide concentration (w/w) and contact time:

 

Bactericidal and yeasticidal - 9.5%, 30 min

 

Fungicidal – 13%, 60 min

 

Virucidal – 13%, 30 min

 

All claimed microbes - 13%, 60 min

Each product label should give information on how the dilution should be made, e.g. to reach 13% (w/w) hydrogen peroxide concentration:

A product with 50% hydrogen peroxide concentration: The product should be diluted to 28% w/v (280 g or 230 mL of product, add water up to 1L).

Remove animals from spaces to be disinfected. Precleaning of surfaces required before using disinfectants.

Spray diluted product 50 -100 mL /m2 on non-porous surfaces. Surface needs to stay wet for the allocated contact time. Allow to drain and dry.

4.2.2.   Use-specific risk mitigation measures

Automated spraying systems:

During the operation worker must leave the area and access must be denied by appropriate barriers or locked doors. After operation efficient ventilation (10 ACH) must be used to reach a safe level. During this period access must also be denied. Air concentrations must be monitored to ensure that no leakage occurs during operations. For re-entry, the undercut of AECinhalation of 1.25 mg/m3 shall be ensured with technical and organisational measures (e.g. sensor, defined ventilation period).

For manual spraying:

The use of eye protection during handling of the product is mandatory.

Wear protective chemical resistant gloves during product handling phase (glove material to be specified by the authorisation holder within the product information).

A protective coverall (at least type 6, EN 13034) shall be worn.

Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory. At least a powered air purifying respirator with helmet/hood/mask (TH1/TM1), or a half/full mask with combination filter gas/P2 is required (filter type (code letter, colour) to be specified by the authorisation holder within the product information).

Only operators wearing the specified RPE should be present while spraying or fumigating.

The operator must walk backward towards the exit while spraying the surfaces so always walking away from sprayed areas.

Efficient ventilation (10 ACH) must be used during spraying and access must be denied by appropriate barriers and notices, Also after operation efficient ventilation (10 ACH) must be used to reach a safe level. During this period access must also be denied. Air concentrations must be monitored to ensure that no leakage occurs during operations. For re-entry, the undercut of AECinhalation of 1.25 mg/m3 shall be ensured with technical and organisational measures (e.g. sensor, defined ventilation period).

No secondary exposure is expected because of rapid decomposition of hydrogen peroxide.

4.2.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use.

4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use.

4.2.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use.

5.   GENERAL DIRECTIONS FOR USE (9) OF THE META SPC 9

5.1.   Instructions for use

-

5.2.   Risk mitigation measures

The use of eye protection during handling of the product is mandatory.

Wear face shield where splashing is possible.

Ensure adequate ventilation during the application.

5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

Particulars of likely direct or indirect adverse effects:

In case of inhalation: Breathing difficulties, cough, pulmonary oedema, nausea, vomiting.

In case of skin contact: Redness, swelling of tissue, skin irritation.

In case of eye contact: Redness, lachrymation, swelling of tissue, severe burns.

In case of ingestion: Nausea, abdominal pain, bloody vomiting, diarrhoea, suffocation, cough, severe shortness of breath, severe burns of the mouth and throat, as well as a danger of perforation of the oesophagus and the stomach. Risk of respiratory disorder.

First aid instructions:

 

IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. If symptoms: Call 112/ambulance for medical assistance. If no symptoms: Call a POISON CENTRE or a doctor.

 

IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor.

 

IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. Call 112/ambulance for medical assistance.

 

IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112/ambulance for medical assistance.

Emergency measures to protect environment in case of accident:

Environmental precautions:

Should not be released into the environment. If the product contaminates rivers and lakes or drains inform respective authorities.

Methods and materials for containment and cleaning up:

Dilute with plenty of water. Dam up. Do not mix waste streams during collection. Soak up with inert absorbent material. Keep in properly labelled containers. Keep in suitable, closed containers for disposal. Never return spills in original containers for re-use.

5.4.   Instructions for safe disposal of the product and its packaging

Do not allow undiluted product to enter the sewer. Do not discharge unused product on the ground, into water courses, into pipes (sink, toilets…) nor down the drains.. Only pass on empty containers/packaging for recycling. Disposal of packaging should at all times comply with the waste disposal legislation and any regional local authority requirements.

5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Storage: Hydrogen peroxide should be stored in properly designed bulk storage tanks or in original vented container in upright position away from incompatible products. Use only approved materials of construction for equipment or approved packs. Store in a cool, ventilated area and protect from damage and direct sunlight. Do not store at temperatures above 40°C. Keep away from combustible materials and sources of ignition and heat.

Shelf-life: 12 months in HDPE packs at ambient temperature.

6.   OTHER INFORMATION

Please be aware of the European reference value of 1.25 mg/m3 for the active substance hydrogen peroxide (CAS No.: 7722-84-1) which was used for the risk assessment for this product.

7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 9

7.1.   Trade name(s), authorisation number and specific composition of each individual product

Trade name(s)

INTEROX BT 50

Market area: EU

Authorisation number

EU-0027468-0015 1-9

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Hydrogen peroxide

 

Active Substance

7722-84-1

231-765-0

49,9


(1)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 1.

(2)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 2.

(3)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 3.

(4)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 4.

(5)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 5.

(6)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 6.

(7)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 7.

(8)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 8.

(9)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 9.


19.7.2022   

EN

Official Journal of the European Union

L 190/70


COMMISSION IMPLEMENTING REGULATION (EU) 2022/1233

of 18 July 2022

amending Implementing Regulation (EU) 2020/492 imposing definitive anti-dumping duties on imports of certain woven and/or stitched glass fibre fabrics originating in the People’s Republic of China and Egypt

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EU) 2016/1036 of the European Parliament and of the Council of 8 June 2016 on protection against dumped imports from countries not members of the European Union (1) (‘the basic Regulation’), and in particular Article 12 thereof,

Whereas:

1.   PROCEDURE

1.1.   Measures in force

(1)

The measures currently in force are definitive anti-dumping duties imposed by Commission Implementing Regulation (EU) 2020/492 on imports of certain woven and/or stitched glass fibre fabrics originating in the People’s Republic of China and Egypt (‘the original measures’) (2).

(2)

The product under investigation is also subject to a definitive countervailing duty imposed by the Commission Implementing Regulation (EU) 2020/776 (3). However, the countervailing duty is not subject to this reinvestigation.

1.2.   Request for an absorption reinvestigation and initiation

(3)

The Commission received a request for an absorption reinvestigation of the anti-dumping measures in force with respect to imports from Egypt (‘country concerned’) pursuant to Article 12 of the basic Regulation.

(4)

The request was lodged on 18 October 2021 by TECH-FAB Europe e.V., an association of EU producers of glass fibre fabrics (‘GFF’) (‘the applicants’), representing more than 25 % of the total Union production of GFF.

(5)

The applicants have submitted sufficient evidence showing that after the original investigation period, Egyptian export prices have decreased. The decrease in Egyptian export prices has seemingly impeded the intended remedial effects of the measures in force. The evidence contained in the request indicated that the decrease in export prices cannot be explained by a decrease of the price of the major raw material and other costs or by a change in the product mix.

1.3.   Reopening of the anti-dumping investigation

(6)

On 1 December 2021, the Commission announced the reopening of the anti-dumping investigation by a notice published in the Official Journal of the European Union (‘the Notice of Reopening’) (4).

(7)

The reinvestigation concerned the current anti-dumping duty of 20 % imposed on Jushi Egypt For Fiberglass Industry S.A.E (‘Jushi Egypt’), Hengshi Egypt Fiberglass Fabrics S.A.E. (‘Hengshi Egypt’) (collectively referred to as ‘CNBM group’) and on ‘All other companies’ as set out in Article 1(2) of Implementing Regulation (EU) 2020/492 (5).

1.4.   Interested parties

(8)

In the Notice of Reopening, the Commission invited interested parties to contact it in order to participate in the reinvestigation. In addition, the Commission specifically informed the applicants, exporting producers and importers known to be concerned and the authorities of the country concerned about the absorption reinvestigation and invited them to participate.

(9)

Interested parties were given the opportunity to make their views known in writing and to request a hearing with the Commission and/or the Hearing Officer in trade proceedings.

1.5.   Sampling of exporting producers in the country concerned to be reinvestigated

(10)

In order to enable the Commission to decide whether sampling in accordance with Article 17 of the basic Regulation would be necessary in respect of the producers in the country concerned, those parties were requested to make themselves known and to provide the Commission with the information requested in the Notice of Reopening. In addition, the Commission requested the Mission of Egypt to the European Union to identify and/or contact other producers, if any, that could be interested in participating in the reinvestigation. However, since only Jushi Egypt and Hengshi Egypt came forward, sampling was not necessary.

1.6.   Sampling of unrelated importers

(11)

In order to decide whether sampling was necessary and, if so, to select a sample, the Commission asked unrelated importers to provide the information specified in the Notice of Reopening. None of the unrelated importers came forward and sampling was therefore not necessary.

1.7.   Replies to the questionnaires and verifications

(12)

The Commission sent a questionnaire to Jushi Egypt and Hengshi Egypt, to which they replied.

(13)

The Commission sought all the information deemed necessary for the purpose of this reinvestigation. In view of the outbreak of COVID-19, the Commission could not carry out verification visits pursuant to Article 16 of the basic Regulation at the premises of Jushi Egypt, Hengshi Egypt and trader related to Hengshi Egypt, Huajin Capital Limited in Hong Kong. The Commission therefore cross-checked remotely all the information deemed necessary of these three companies for its determinations in line with its Notice on the consequences of the COVID-19 outbreak on anti-dumping and anti-subsidy investigations (6).

(14)

Furthermore, verification visits pursuant to Article 16 of the basic Regulation were carried out at the premises of the following importers/traders related to Jushi Egypt/Hengshi Egypt:

Jushi France S.A.S, France

JUSHI SPAIN, S.A., Spain

1.8.   Period covered by the absorption reinvestigation

(15)

The absorption reinvestigation period (‘AIP’) was 1 October 2020 to 30 September 2021. The original investigation period (‘OIP’) was 1 January 2018 to 31 December 2018.

1.9.   Comments on initiation

(16)

Following the initiation of this re-investigation the Government of Egypt (‘GoE’) submitted that a reinvestigation under Article 12 of the basic Regulation would be incompatible with the WTO anti-dumping agreement (ADA). The GoE claimed (i) that under WTO previsions no such review is provided for; (ii) that Article 12(3) of the basic Regulation would be incompatible with Article 9.1. ADA insofar as a lower duty cannot be imposed as a result of such reinvestigation and (iii) that measures imposed following a reinvestigation in accordance with Article 12 of the basic Regulation would also not fall within the exceptions granted by Article XX(d) of the GATT 1994.

(17)

The GoE also submitted that in contrast with the obligations under Article 11(3) of the ADA a reinvestigation in accordance with Article 12 of the basic Regulation does not require an investigation of injury.

(18)

The Commission noted that the fact that ADA does not explicitly provide for the possibility to review the dumping margin to take into account the absorption of anti-dumping duties does not mean that such a review would be WTO inconsistent. On the contrary, such review focuses on the dumping margin determination to ensure that the level of duties can adequately eliminate the effects of injurious dumping and is therefore warranted under Articles 11.1 and 11.2 of the ADA, and in full conformity with the applicable ADA rules including Article 2.

(19)

As regards the claim on Article 12(3) of the basic Regulation, it is noted that the present reinvestigation did not establish a lower dumping margin on imports of GFF from Egypt. The claim is therefore immaterial.

(20)

Concerning the requirement that the investigation should cover both dumping and injury, unlike reviews under Article 11(3), Article 12 is limited to reinvestigating the dumping margins only. In any event, in the present investigation the Commission did review the injury elimination level in order to fully comply with the relevant rules concerning the level of the duty.

(21)

The GoE also claimed that the measures in force had the intended remedial effect and that significant decrease in the volume of GFF imports between 2018 and 2020 proved the absence of absorption practices by the exporters. In its response to the final disclosure, GoE restated its argument that the Commission did not objectively examine the volume of the dumped imports and the effect of such imports on prices in the Union market for like products. First, Article 12 of the basic Regulation does not prevent the Commission from conducting absorption reinvestigation and from possibly increasing the antidumping measures in the event of decreasing imports from the country concerned. Second, changes in import volumes, as such, do not constitute or influence the absorption of anti-dumping duties in terms of changes in export prices. Third, while the imports of GFF into the Union decreased after the imposition of the anti-dumping duties, they remain sizeable and, as a matter of fact, one of the two exporting producers doubled its exports to the Union in the AIP. Hence, this claim is rejected.

(22)

Vestas Wind Systems A/S (‘Vestas’), a GFF user, submitted during the reinvestigation that based on its records, both the FOB price and the landed costs Vestas paid for GFF imported from Egypt to the Union have increased. In this respect, the Commission noted the following. First, the Commission’s assessment of export sales is based on collected and verified sales data provided by the exporting producers which show a decrease in export prices in the AIP as compared to the OIP. Second, the Commission’s assessment is based on totality of sales to all independent customers in the Union during the AIP and OIP respectively and is not limited to analysis of sales to individual customers. Therefore, the claim raised by Vestas is rejected.

(23)

Furthermore, Vestas argued that that imposing or increasing anti-dumping duties on GFF is directly contrary to the interest of the Union. It is noted that the current reinvestigation is limited to the determination whether export prices have decreased or whether there has been no movement, or insufficient movement, in resale prices or subsequent selling prices in the Union of the product under investigation since the imposition of the original measures and subsequently, if applicable to recalculate the dumping margin based on the re-assessed export prices. In accordance with Article 12 of the basic Regulation such reinvestigation does not include Union interest’s aspects. Therefore, the claim is dismissed.

2.   PRODUCT UNDER INVESTIGATION

(24)

The product under investigation is fabrics of woven and/or stitched continuous filament glass fibre rovings and/or yarns with or without other elements, excluding products which are impregnated or pre-impregnated (pre-preg) and excluding open mesh fabric with cells with a size of more than 1,8 mm in both length and width and weighing more than 35 g/m2, originating in Egypt currently falling under CN codes ex 7019 61 00, ex 7019 62 00, ex 7019 63 00, ex 7019 64 00, ex 7019 65 00, ex 7019 66 00, ex 7019 69 10, ex 7019 69 90 and ex 7019 90 00 (TARIC codes 7019610081, 7019610083, 7019610084, 7019620081, 7019620083, 7019620084, 7019630081, 7019630083, 7019630084, 7019640081, 7019640083, 7019640084, 7019650081, 7019650083, 7019650084, 7019660081, 7019660083, 7019660084, 7019691081, 7019691083, 7019691084, 7019699081, 7019699083, 7019699084, 7019900081, 7019900083 and 7019900084) (‘the product under investigation’).

3.   FINDINGS OF THE ABSORPTION REINVESTIGATION

(25)

The absorption reinvestigation pursuant to Article 12 of the basic Regulation aims at establishing whether or not export prices have decreased or whether there has been no movement, or insufficient movement, in resale prices or subsequent selling prices in the Union of the product under investigation since the imposition of the original measures. As a second step, if it is concluded that the measure should have led to movements in such prices, then, in order to remove the injury previously established in accordance with Article 3 of the basic Regulation, export prices shall be reassessed in accordance with Article 2 of the basic Regulation and dumping margins shall be recalculated to take account of the reassessed export prices.

3.1.   Decrease of export prices

(26)

In this case, both exporting producers exported to the Union either directly to independent customers or through related companies and the Commission analysis focused accordingly on the evolution of export prices in the AIP as compared to the OIP.

(27)

When establishing whether there was a decrease in export prices, the Commission established for each examined company its cost, insurance and freight (CIF) export prices at the Union custom border during the AIP and compared these prices to the corresponding export prices determined in the OIP.

(28)

The Commission compared for each of the exporting producer the prices of the product types sold in the AIP with the same product types sold in the OIP and calculated for them the weighted average price difference.

(29)

The above comparison made for the two related exporting producers resulted in a weighted average export price decrease of 12 % for CNBM group, indicating prima facie that absorption of the measures in force was taking place.

(30)

Therefore, dumping margins were recalculated, according to Article 2 of the basic Regulation.

3.2.   Dumping

3.2.1.   Introduction

(31)

After having established possible absorption for CNBM group, the dumping margin was recalculated, according to Article 2 of the basic Regulation.

(32)

With respect to the export prices, the export prices for the AIP, collected and verified or cross-checked in the framework of this reinvestigation were used, pursuant to Article 12(2) of the basic Regulation.

(33)

In this case, both related exporting producers exported to the Union either directly to independent customers or through related companies, established in Hong Kong or the Union.

(34)

Where the exporting producers exported the product under investigation directly to independent customers in the Union, the export price was the price actually paid or payable for the product under investigation when sold for export to the Union, in accordance with Article 2(8) of the basic Regulation.

(35)

Where the exporting producers exported the product under investigation to the Union through a related company acting as an importer, the export price was established on the basis of the price at which the imported product was first resold to independent customers in the Union, in accordance with Article 2(9) of the basic Regulation. In that case, adjustments to the price were made for all costs incurred between importation and resale including SG&A expenses of the related importers located in the Union, and reasonable profit (established at 5 % in the original investigation).

(36)

Normal values as established in the original investigation are used for the calculation of dumping margins during the AIP, unless revision of the normal value taking into account changes in the AIP is requested under Article 12(5) of the basic Regulation.

(37)

In the present case, the exporting producers did not request a revision of the normal value. Therefore, the normal values used to recalculate the dumping margin in this case are the ones established in the original investigation.

(38)

For Jushi Egypt, all product types sold in the AIP were also sold in the OIP and hence all normal values were readily available. For Hengshi Egypt, two product types sold in the AIP were not sold in the OIP. Normal value for those two products was therefore replaced by the normal value for the most closely resembling product types sold by Hengshi Egypt in the original investigation.

(39)

Hengshi Egypt claimed in its reply to the final disclosure that for one of the product types, it is inappropriate to use the normal value from the OIP, given that such product type was only made as part of a trial production and sold in a small quantity as a sample. Instead, Hengshi Egypt suggested that the normal value from the OIP for another, allegedly nearest product type be used.

(40)

First, it is noted that the original investigation established that the product type in question was produced for commercial use and the normal value for the said product type was duly established and used for dumping margin calculation in the OIP. None of these determinations were contested by Hengshi Egypt in the original investigation. Second, using arbitrarily a normal value for a different product type, while the established and previously uncontested normal value for the matching product type is available would be unfounded. The statements made by the company following the final disclosure could also not be verified. The Commission therefore maintains that the normal value for the product type produced and commercially sold in the OIP (albeit in limited quantities) and corresponding to the product type sold to the Union in the AIP is the closest and most reliable proxy to be used for dumping calculations in this case.

(41)

In addition, although Hengshi Egypt could have requested a revision of the normal value based on Article 12(5) of the basic Regulation, if it considered that changes in normal values occurred in the AIP that merited re-examination, it did not do so. Nevertheless, while Article 12(5) of the basic Regulation allows for an en bloc revision of the normal value, it does not allow for a selective reassessment for only one or a few select product types. In light of the above, the claim raised by Hengshi Egypt has to be rejected.

(42)

In response to the final disclosure, Jushi Egypt disagreed to treat both Jushi Egypt as well as Hengshi Egypt jointly for the purposes of applying Article 12(5) of the basic Regulation on revision of normal values. Jushi Egypt suggests that the Commission should have accepted its individual request for reassessment of the normal value.

(43)

Jushi Egypt submitted that while it itself contributed to the alleged export price decrease for the whole CNBM group, Hengshi Egypt’s export prices remained at the same level as during the OIP. The decrease in Jushi Egypt’s export prices, however, would be the result of Jushi Egypt’s effort in lowering its costs in the AIP, and there would therefore be an equal effect of the decrease in costs on the normal value. In conclusion, Jushi Egypt argues that therefore its export prices were not absorbed and consequently neither the export prices of the CNBM group. Moreover, according to Jushi Egypt, the single dumping margin for the company group should have been based on the revised dumping margin for Jushi Egypt and the original dumping margin for Hengshi Egypt.

(44)

First, as outlined in recital (29), it is noted that an export price decrease of 12 % was established for the CNBM group comprising both Jushi Egypt and Hengshi Egypt, which led to the recalculation of dumping margins for both producing entities pursuant to Article 12(2) of the basic Regulation.

(45)

Second, it is recalled that the CNBM group explicitly stated that it would not seek revision of the normal value for their related exporting producers, Jushi Egypt and Hengshi Egypt. The Commission subsequently proceeded, in accordance with Article 12 of the basic Regulation, with recalculating the dumping margins based on the normal values from the OIP.

(46)

Third, pursuant to Article 9(5), second subparagraph of the basic Regulation, suppliers with existing structural and corporate links may be considered as a single entity for the purpose of specifying the antidumping duty. This implies that a uniform approach at the level of the group of related producers is to be adopted also in applying Article 12(5) and in conducting absorption reinvestigations. Otherwise, disparate approaches applied to individual exporting producers belonging to the same group already at preliminary stages of absorption reinvestigations could result in a distorted outcome of the reinvestigations and situations, where the exporting producers escape application of (increased) antidumping duties. It is further noted with regards to the treatment of Jushi Egypt and Hengshi Egypt as pertaining to the same corporate group that the approach taken by the Commission in this reinvestigation is fully consistent with the approach adopted in the original investigation. For the reasons set out above, Jushi Egypt’s claim has to be rejected.

3.2.2.   Comparison

(47)

The Commission compared the normal value and the export price of the two cooperating exporting producers on an ex-works basis.

(48)

Where justified by the need to ensure a fair comparison, the Commission adjusted the normal value and/or the export price for differences affecting prices and price comparability, in accordance with Article 2(10) of the basic Regulation. Adjustments in this case were made for transport, insurance, handling, loading costs, credit cost and bank charges.

(49)

Furthermore, during the AIP, Hengshi Egypt exported GFF to the Union also through a related trader located outside the Union, in Hong Kong. Therefore, an adjustment under Article 2(10)(i) was also made for sales through that related trading company in line with the original investigation. The adjustment consisted of the deduction of SG&A of the trading company and a 5 % profit (as established in the original investigation).

3.2.3.   Dumping margin

(50)

In order to establish the dumping margin for the two cooperating exporting producers, the Commission compared the weighted average normal value of each type of the like product with the weighted average export price of the corresponding type of the product under investigation, on an ex-works basis, in accordance with Article 2(11) and (12) of the basic Regulation.

(51)

As the two cooperating producers were related, a single dumping margin was established based on the weighted average of their individual dumping margins.

(52)

On this basis, the weighted average dumping margins expressed as a percentage of the CIF Union frontier price, duty unpaid, developed as follows:

Company name

Dumping margin in OIP (%)

Dumping margin in AIP (%)

Increase of the dumping margin (p.p.)

CNBM group

20

33,1

13,1

3.2.4.   Injury elimination level

(53)

The Commission then determined the injury elimination level based on a comparison of the weighted average import price of CNBM group established in the AIP with the weighted average non-injurious price of the like product sold by the sampled Union producers on the Union market as established during the OIP. Any difference resulting from this comparison was expressed as a percentage of the weighted average import CIF value.

(54)

On that basis, the injury margin for CNBM group increased from 63,9 % to 109,3 %.

(55)

In response to the final disclosure. CNBM group and GoE claimed with reference to the decreasing level of imports from Egypt and the resulting decrease of CNBM market share in the Union that the anti-dumping measures in place have already well protected the Union industry, which has recovered or had opportunity to recover from the alleged material injury. Referring to a parallel anti-circumvention investigation (7) the CNBM group also claimed that selling prices of the Union producers were allegedly increasing, showing that the Union industry had recovered from the material injury suffered. CNBM group further contested the methodology used by the Commission in computing the undercutting and underselling margins, referring to their submissions in the original investigation as well as two judgments of the Court of Justice in this regard (8). Moreover, GoE submitted in response to the final disclosure that in reviewing the injury elimination margin, the Commission used a different level of trade to compare prices and thus failed to act consistently with Article 3 of the ADA on fair comparison.

(56)

As set out in recital (20), the present reinvestigation is limited to dumping aspects only. The injury elimination level was recalculated solely in order to fully comply with the relevant rules concerning the level of the duty and cannot affect the outcome of this reinvestigation, as the duties in both the original investigation as well as in this reinvestigation are set at the level of the dumping margin (see recital (58) for more details). Regarding to the use of information from a parallel investigation, it is to be noted that CNBM refers to a different investigation and to information that is not available on the case file in the present case. Hence even if such information were to be relevant for the purposes of this case (which is not), it could not be used in this case. In the light of the above, the CNBM group’s and GoE’s claims have to be rejected.

4.   CONCLUSION

(57)

The dumping margin calculated for the AIP increased compared to that established in the OIP. Hence, anti-dumping measures imposed on imports of the product under investigation by the CNBM group should be amended in accordance with Article 12(3) of the basic Regulation.

(58)

In accordance with Article 9(4) of the basic Regulation, the amount of the duties should be set at the level of the dumping margin. In the original anti-subsidy investigation (9), the Commission did not countervail any export contingent subsidy schemes in accordance with Article 24(1) of Regulation (EU) 2016/1037 of the European Parliament and of the Council (10) (the basic Anti-subsidy Regulation) . Therefore, the countervailing duty does not need to be deducted in order to determine the new anti-dumping duty.

(59)

Consequently, the revised rate of anti-dumping duty applicable, before duty, to the net free-at-Union-frontier price will be as follows:

Company

Definitive dumping margin

CNBM group

33,1  %

All other companies

33,1  %

(60)

In reply to the final disclosure, the applicants submitted that, because of the massive increase in undercutting, the Commission should use its full discretion and double the anti-dumping duty.

(61)

It is observed that the Commission acted in conformity with Article 9(4), 12(2) and 12(3) of the basic Regulation by recalculating the dumping margin to take account of the lower export prices and setting the revised antidumping duty at the level of the established dumping margin. The Commission is bound by the said provisions and contrary to the applicants’ claim does not enjoy any discretion in setting the duty beyond the level of the dumping margin in this case. Therefore, the applicants’ claim has no legal foundation and has to be dismissed.

(62)

On 17 May 2022, the Commission disclosed the essential facts and considerations on the basis of which it intended to impose a definitive anti-dumping duty on imports of GFF originating in Egypt. All parties were granted a period within which they could make comments on the disclosure. The comments submitted by interested parties were considered and taken into account where warranted.

(63)

The measures provided for in this Regulation are in accordance with the opinion of the Committee established by Article 15(1) of Regulation (EU) 2016/1036.

HAS ADOPTED THIS REGULATION:

Article 1

In Implementing Regulation (EU) 2020/492, Article 1(1) and 1(2) shall be replaced by the following:

‘1.   A definitive anti-dumping duty is imposed on imports of fabrics of woven and/or stitched continuous filament glass fibre rovings and/or yarns with or without other elements, excluding products which are impregnated or pre-impregnated (pre-preg), and excluding open mesh fabrics with cells with a size of more than 1,8 mm in both length and width and weighing more than 35 g/m 2, originating in the People’s Republic of China and Egypt, currently falling under CN codes ex 7019 61 00, ex 7019 62 00, ex 7019 63 00, ex 7019 64 00, ex 7019 65 00, ex 7019 66 00, ex 7019 69 10, ex 7019 69 90 and ex 7019 90 00 (TARIC codes 7019610081, 7019610083, 7019610084, 7019620081, 7019620083, 7019620084, 7019630081, 7019630083, 7019630084, 7019640081, 7019640083, 7019640084, 7019650081, 7019650083, 7019650084, 7019660081, 7019660083, 7019660084, 7019691081, 7019691083, 7019691084, 7019699081, 7019699083, 7019699084, 7019900081, 7019900083 and 7019900084).

2.   The definitive anti-dumping duty applicable to the net, free-at-Union-frontier price, before duty, of the product described in paragraph 1 and produced by the companies listed below shall be as follows:

Country concerned

Company

Definitive anti-dumping duty

TARIC additional code

PRC

Jushi Group Co. Ltd;

Zhejiang Hengshi Fiberglass Fabrics Co. Ltd;

Taishan Fiberglass Inc.

69,0  %

C531

PGTEX China Co. Ltd;

Chongqing Tenways Material Corp.

37,6  %

C532

Other companies cooperating in both anti-subsidy and anti-dumping investigation listed in Annex I

37,6  %

See Annex I

Other companies cooperating in anti-dumping investigation but not in anti-subsidy investigation listed in Annex II

34,0  %

See Annex II

All other companies

69,0  %

C999

Egypt

Jushi Egypt For Fiberglass Industry S.A.E;

Hengshi Egypt Fiberglass Fabrics S.A.E.

33,1  %

C533

All other companies

33,1  %

C999’

Article 2

This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 18 July 2022.

For the Commission

The President

Ursula VON DER LEYEN


(1)  OJ L 176, 30.6.2016, p. 21.

(2)  Commission Implementing Regulation (EU) 2020/492 of 1 April 2020 imposing definitive anti-dumping duties on imports of certain woven and/or stitched glass fibre fabrics originating in the People’s Republic of China and Egypt (OJ L 108, 6.4.2020, p. 1).

(3)  Commission Implementing Regulation (EU) 2020/776 of 12 June 2020 imposing definitive countervailing duties on imports of certain woven and/or stitched glass fibre fabrics originating in the People’s Republic of China and Egypt and amending Commission Implementing Regulation (EU) 2020/492 imposing definitive anti-dumping duties on imports of certain woven and/or stitched glass fibre fabrics originating in the People’s Republic of China and Egypt (OJ L 189, 15.6.2020, p. 1).

(4)  Notice of reopening the anti-dumping investigation concerning imports of certain woven and/or stitched glass fibre fabrics originating in Egypt (OJ C 483, 1.12.2021, p. 29).

(5)  Implementing Regulation (EU) 2020/492, amended by Implementing Regulation (EU) 2020/776.

(6)  Notice on the consequences of the COVID-19 outbreak on anti-dumping and anti-subsidy investigations (OJ C 86, 16.3.2020. p. 6).

(7)  See Commission Implementing Regulation (EU) 2021/2230 of 14 December 2021 initiating an investigation concerning possible circumvention of the anti-dumping measures imposed by Commission Implementing Regulation (EU) 2020/492 on imports of certain woven and/or stitched glass fibre fabrics originating in People’s Republic of China and Egypt by imports of certain woven and/or stitched glass fibre fabrics consigned from Turkey, whether declared as originating in Turkey or not, and making such imports subject to registration (OJ L 448, 15.12.2021, p. 58).

(8)  Case T-242/19, Giant Electric Vehicle Kunshan v. Commission, ECLI:EU:T:2022:259, paragraph 90; Cases T-30/19 and T-72/19, CRIA and CCCMC v. Commission, ECLI:EU:T:2022:266, paragraph 153.

(9)  Implementing Regulation (EU) 2020/776.

(10)  Regulation (EU) 2016/1037 of the European Parliament and of the Council of 8 June 2016 on protection against subsidised imports from countries not members of the European Union (OJ L 176, 30.6.2016, p. 55).


19.7.2022   

EN

Official Journal of the European Union

L 190/79


COMMISSION IMPLEMENTING REGULATION (EU) 2022/1234

of 18 July 2022

amending Annex I to Implementing Regulation (EU) 2021/605 laying down special control measures for African swine fever

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EU) 2016/429 of the European Parliament and of the Council of 9 March 2016 on transmissible animal diseases and amending and repealing certain acts in the area of animal health (‘Animal Health Law’) (1), and in particular Article 71(3) thereof,

Whereas:

(1)

African swine fever is an infectious viral disease affecting kept and wild porcine animals and can have a severe impact on the concerned animal population and the profitability of farming causing disturbance to movements of consignments of those animals and products thereof within the Union and exports to third countries.

(2)

Commission Implementing Regulation (EU) 2021/605 (2) was adopted within the framework of Regulation (EU) 2016/429, and it lays down special disease control measures regarding African swine fever to be applied for a limited period of time by the Member States listed in Annex I thereto (the Member States concerned), in restricted zones I, II and III listed in that Annex.

(3)

The areas listed as restricted zones I, II and III in Annex I to Implementing Regulation (EU) 2021/605 are based on the epidemiological situation of African swine fever in the Union. Annex I to Implementing Regulation (EU) 2021/605 was last amended by Commission Implementing Regulation (EU) 2022/1196 (3) following changes in the epidemiological situation as regards that disease in Germany and Poland.

(4)

Any amendments to restricted zones I, II and III in Annex I to Implementing Regulation (EU) 2021/605 should be based on the epidemiological situation as regards African swine fever in the areas affected by that disease and the overall epidemiological situation of African swine fever in the Member State concerned, the level of risk for the further spread of that disease, as well as scientifically based principles and criteria for geographically defining zoning due to African swine fever and the Union’s guidelines agreed with the Member States at the Standing Committee on Plants, Animals, Food and Feed and publicly available on the Commission’s website (4). Such amendments should also take account of international standards, such as the Terrestrial Animal Health Code (5) of the World Organisation for Animal Health and justifications for zoning provided by the competent authorities of the Member States concerned.

(5)

There have been new outbreaks of African swine fever in kept porcine animals in Latvia and Lithuania.

(6)

In July 2022, several outbreaks of African swine fever in kept porcine animals were observed in the Kuldigas and Ventspils counties in Latvia in areas currently listed as restricted zones II in Annex I to Implementing Regulation (EU) 2021/605. Those new outbreaks of African swine fever in kept porcine animals constitute an increased level of risk, which should be reflected in that Annex. Accordingly, those areas of Latvia currently listed as restricted zones II in that Annex, should now be listed as restricted zones III in that Annex instead of as restricted zones II thereof and the current boundaries of restricted zones II also need to be redefined to take account of those recent outbreaks.

(7)

Also, in July 2022, one outbreak of African swine fever in kept porcine animals was observed in the Marijampoles county in Lithuania in an area currently listed as restricted zone II in Annex I to Implementing Regulation (EU) 2021/605. This new outbreak of African swine fever in kept porcine animals constitutes an increased level of risk, which should be reflected in that Annex. Accordingly, this area of Lithuania currently listed as restricted zone II in that Annex, should now be listed as restricted zone III in that Annex instead of as restricted zone II thereof and the current boundaries of restricted zone II also need to be redefined to take account of this recent outbreak.

(8)

Following those recent outbreaks of African swine fever in kept porcine animals in Latvia and Lithuania and taking into account the current epidemiological situation as regards African swine fever in the Union, zoning in those Member States has been reassessed and updated. In addition, the risk management measures in place have also been reassessed and updated. These changes should be reflected in Annex I to Implementing Regulation (EU) 2021/605.

(9)

In order to take account of the recent developments in the epidemiological situation of African swine fever in the Union, and in order to combat the risks associated with the spread of that disease in a proactive manner, new restricted zones of a sufficient size should be demarcated for Latvia and Lithuania and duly listed as restricted zones II and III in Annex I to Implementing Regulation (EU) 2021/605. As the situation as regards African swine fever is very dynamic in the Union, when demarcating those new restricted zones, account has been taken of the situation in the surrounding areas.

(10)

Given the urgency of the epidemiological situation in the Union as regards the spread of African swine fever, it is important that the amendments to be made to Annex I to Implementing Regulation (EU) 2021/605 by this Implementing Regulation take effect as soon as possible.

(11)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

HAS ADOPTED THIS REGULATION:

Article 1

Annex I to Implementing Regulation (EU) 2021/605 is replaced by the text set out in the Annex to this Regulation.

Article 2

This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 18 July 2022.

For the Commission

The President

Ursula VON DER LEYEN


(1)  OJ L 84, 31.3.2016, p. 1.

(2)  Commission Implementing Regulation (EU) 2021/605 of 7 April 2021 laying down special control measures for African swine fever (OJ L 129, 15.4.2021, p. 1).

(3)  Commission Implementing Regulation (EU) 2022/1196 of 11 July 2022 amending Annex I to Implementing Regulation (EU) 2021/605 laying down special control measures for African swine fever (OJ L 185, 12.7.2022, p. 77).

(4)  Working Document SANTE/7112/2015/Rev. 3 “Principles and criteria for geographically defining ASF regionalisation”. https://ec.europa.eu/food/animals/animal-diseases/control-measures/asf_en

(5)  OIE Terrestrial Animal Health Code, 29th Edition, 2021. Volumes I and II ISBN 978-92-95115-40-8; https://www.woah.org/en/what-we-do/standards/codes-and-manuals/terrestrial-code-online-access/


ANNEX

Annex I to Implementing Regulation (EU) 2021/605 is replaced by the following:

‘ANNEX I

RESTRICTED ZONES

PART I

1.   Germany

The following restricted zones I in Germany:

Bundesland Brandenburg:

Landkreis Dahme-Spreewald:

Gemeinde Alt Zauche-Wußwerk,

Gemeinde Byhleguhre-Byhlen,

Gemeinde Märkische Heide, mit den Gemarkungen Alt Schadow, Neu Schadow, Pretschen, Plattkow, Wittmannsdorf, Schuhlen-Wiese, Bückchen, Kuschkow, Gröditsch, Groß Leuthen, Leibchel, Glietz, Groß Leine, Dollgen, Krugau, Dürrenhofe, Biebersdorf und Klein Leine,

Gemeinde Neu Zauche,

Gemeinde Schwielochsee mit den Gemarkungen Groß Liebitz, Guhlen, Mochow und Siegadel,

Gemeinde Spreewaldheide,

Gemeinde Straupitz,

Landkreis Märkisch-Oderland:

Gemeinde Müncheberg mit den Gemarkungen Müncheberg, Eggersdorf bei Müncheberg und Hoppegarten bei Müncheberg,

Gemeinde Bliesdorf mit den Gemarkungen Kunersdorf - westlich der B167 und Bliesdorf - westlich der B167

Gemeinde Märkische Höhe mit den Gemarkungen Reichenberg und Batzlow,

Gemeinde Wriezen mit den Gemarkungen Haselberg, Frankenfelde, Schulzendorf, Lüdersdorf Biesdorf, Rathsdorf - westlich der B 167 und Wriezen - westlich der B167

Gemeinde Buckow (Märkische Schweiz),

Gemeinde Strausberg mit den Gemarkungen Hohenstein und Ruhlsdorf,

Gemeine Garzau-Garzin,

Gemeinde Waldsieversdorf,

Gemeinde Rehfelde mit der Gemarkung Werder,

Gemeinde Reichenow-Mögelin,

Gemeinde Prötzel mit den Gemarkungen Harnekop, Sternebeck und Prötzel östlich der B 168 und der L35,

Gemeinde Oberbarnim,

Gemeinde Bad Freienwalde mit der Gemarkung Sonnenburg,

Gemeinde Falkenberg mit den Gemarkungen Dannenberg, Falkenberg westlich der L 35, Gersdorf und Kruge,

Gemeinde Höhenland mit den Gemarkungen Steinbeck, Wollenberg und Wölsickendorf,

Landkreis Barnim:

Gemeinde Joachimsthal östlich der L220 (Eberswalder Straße), östlich der L23 (Töpferstraße und Templiner Straße), östlich der L239 (Glambecker Straße) und Schorfheide (JO) östlich der L238,

Gemeinde Friedrichswalde mit der Gemarkung Glambeck östlich der L 239,

Gemeinde Althüttendorf,

Gemeinde Ziethen mit den Gemarkungen Groß Ziethen und Klein Ziethen westlich der B198,

Gemeinde Chorin mit den Gemarkungen Golzow, Senftenhütte, Buchholz, Schorfheide (Ch), Chorin westlich der L200 und Sandkrug nördlich der L200,

Gemeinde Britz,

Gemeinde Schorfheide mit den Gemarkungen Altenhof, Werbellin, Lichterfelde und Finowfurt,

Gemeinde (Stadt) Eberswalde mit der Gemarkungen Finow und Spechthausen und der Gemarkung Eberswalde südlich der B167 und westlich der L200,

Gemeinde Breydin,

Gemeinde Melchow,

Gemeinde Sydower Fließ mit der Gemarkung Grüntal nördlich der K6006 (Landstraße nach Tuchen), östlich der Schönholzer Straße und östlich Am Postweg,

Hohenfinow südlich der B167,

Landkreis Uckermark:

Gemeinde Passow mit den Gemarkungen Briest, Passow und Schönow,

Gemeinde Mark Landin mit den Gemarkungen Landin nördlich der B2, Grünow und Schönermark,

Gemeinde Angermünde mit den Gemarkungen Frauenhagen, Mürow, Angermünde nördlich und nordwestlich der B2, Dobberzin nördlich der B2, Kerkow, Welsow, Bruchhagen, Greiffenberg, Günterberg, Biesenbrow, Görlsdorf, Wolletz und Altkünkendorf,

Gemeinde Zichow,

Gemeinde Casekow mit den Gemarkungen Blumberg, Wartin, Luckow-Petershagen und den Gemarkungen Biesendahlshof und Casekow westlich der L272 und nördlich der L27,

Gemeinde Hohenselchow-Groß Pinnow mit der Gemarkung Hohenselchow nördlich der L27,

Gemeinde Tantow,

Gemeinde Mescherin

Gemeinde Gartz (Oder) mit der Gemarkung Geesow sowie den Gemarkungen Gartz und Hohenreinkendorf nördlich der L27 und B2 bis Gartenstraße,

Gemeinde Pinnow nördlich und westlich der B2,

Gemeinde Nordwestuckermark mit den Gemarkungen Zernikow, Holzendorf, Rittgarten, Falkenhagen, Schapow, Schönermark (NWU), Wilhelmshof, Naugarten, Horst, Gollmitz, Klein-Sperrenwalde und Kröchlendorff,

Gemeinde Boitzenburger-Land mit den Gemarkungen Berkholz, Wichmannsdorf, Kuhz und Haßleben,

Gemeinde Mittenwalde,

Gemeinde Gerswalde mit den Gemarkungen Gerswalde, Buchholz, Pinnow (GE), Kaakstedt und Fergitz

Gemeinde Flieth-Steglitz,

Gemeinde Angermünde mit den Gemarkungen Wilmersdorf und Schmiedeberg,

Gemeinde Oberuckersee mit der Gemarkung Grünheide,

Gemeinde Gramzow mit der Gemarkung Gramzow östlich der der K7315, Gemarkungen

Meichow, Neumeichow, Polßen

Gemeinde Randowtal mit den Gemarkungen Wollin, Schmölln, Schwaneberg, Grenz

Gemeinde Brüssow mit den Gemarkungen Battin, Grünberg und Trampe,

Gemeinde Carmzow-Wallmow.

Gemeinde Grünow mit der Gemarkung Grenz,

Gemeinde Schenkenberg mit der Gemarkung Kleptow,

Gemeinde Schönfeld,

Gemeinde Göritz,

Gemeinde Prenzlau mit den Gemarkungen Dedelow, Schönwerder und Dauer,

Gemeinde Uckerland mit der Gemarkung Bandelow südlich der Straße von Bandelow zum Bandlowsee und der Gemarkung Jagow südlich der Straße vom Bandlowsee zur K7341,

Landkreis Oder-Spree:

Gemeinde Storkow (Mark),

Gemeinde Spreenhagen mit den Gemarkungen Braunsdorf, Markgrafpieske, Lebbin und Spreenhagen,

Gemeinde Grünheide (Mark) mit den Gemarkungen Kagel, Kienbaum und Hangelsberg,

Gemeinde Fürstenwalde westlich der B 168 und nördlich der L 36,

Gemeinde Rauen,

Gemeinde Wendisch Rietz bis zur östlichen Uferzone des Scharmützelsees und von der südlichen Spitze des Scharmützelsees südlich der B246,

Gemeinde Reichenwalde,

Gemeinde Bad Saarow mit der Gemarkung Petersdorf und der Gemarkung Bad Saarow-Pieskow westlich der östlichen Uferzone des Scharmützelsees und ab nördlicher Spitze westlich der L35,

Gemeinde Tauche mit der Gemarkung Werder,

Gemeinde Steinhöfel mit den Gemarkungen Jänickendorf, Schönfelde, Beerfelde, Gölsdorf, Buchholz, Tempelberg und den Gemarkungen Steinhöfel, Hasenfelde und Heinersdorf westlich der L36 und der Gemarkung Neuendorf im Sande nördlich der L36,

Landkreis Spree-Neiße:

Gemeinde Turnow-Preilack mit der Gemarkung Turnow,

Gemeinde Drachhausen,

Gemeinde Schmogrow-Fehrow,

Gemeinde Drehnow,

Gemeinde Teichland mit den Gemarkungen Maust und Neuendorf,

Gemeinde Dissen-Striesow,

Gemeinde Briesen,

Gemeinde Spremberg mit den Gemarkungen, Klein Buckow, Radewiese, Stradow, Straußdorf, Wolkenberg und der Gemarkung Spremberg westlich der Tagebaurandstraße,

Gemeinde Drebkau mit den Gemarkungen Jehserig und Kausche,

Gemeinde Neuhausen/Spree mit den Gemarkungen Kathlow, Haasow, Koppatz, Neuhausen, Frauendorf, Groß Oßnig, Groß Döbbern und Klein Döbbern und der Gemarkung Roggosen nördlich der BAB 15,

Gemeinde Welzow mit der Gemarkung Welzow,

Landkreis Oberspreewald-Lausitz:

Gemeinde Neupetershain,

Gemeinde Lauchhammer,

Gemeinde Schwarzheide,

Gemeinde Schipkau,

Gemeinde Senftenberg mit den Gemarkungen Brieske, Niemtsch, Senftenberg, Reppist, Hosena, Großkoschen, Kleinkoschen und Sedlitz,

die Gemeinde Schwarzbach mit der Gemarkung Biehlen,

Gemeinde Neu-Seeland mit den Gemarkungen Lieske, Bahnsdorf und Lindchen,

Gemeinde Großräschen mit den Gemarkungen Dörrwalde und Allmosen,

Gemeinde Tettau,

Landkreis Elbe-Elster:

Gemeinde Großthiemig,

Gemeinde Hirschfeld,

Gemeinde Gröden,

Gemeinde Schraden,

Gemeinde Merzdorf,

Gemeinde Röderland mit der Gemarkung Wainsdorf, Prösen, Stolzenhain a.d. Röder,

Gemeinde Plessa mit der Gemarkung Plessa,

Landkreis Prignitz:

Gemeinde Groß Pankow mit den Gemarkungen Baek, Tangendorf, Tacken, Hohenvier, Strigleben, Steinberg und Gulow,

Gemeinde Perleberg mit der Gemarkung Schönfeld,

Gemeinde Karstädt mit den Gemarkungen Postlin, Strehlen, Blüthen, Klockow, Premslin, Glövzin, Waterloo, Karstädt, Dargardt, Garlin und die Gemarkungen Groß Warnow, Klein Warnow, Reckenzin, Streesow und Dallmin westlich der Bahnstrecke Berlin/Spandau-Hamburg/Altona,

Gemeinde Gülitz-Reetz,

Gemeinde Putlitz mit den Gemarkungen Lockstädt, Mansfeld und Laaske,

Gemeinde Triglitz,

Gemeinde Marienfließ mit der Gemarkung Frehne,

Gemeinde Kümmernitztal mit der Gemarkungen Buckow, Preddöhl und Grabow,

Gemeinde Gerdshagen mit der Gemarkung Gerdshagen,

Gemeinde Meyenburg,

Gemeinde Pritzwalk mit der Gemarkung Steffenshagen,

Bundesland Sachsen:

Landkreis Bautzen

Gemeinde Arnsdorf, sofern nicht bereits Teil der Sperrzone II,

Gemeinde Cunewalde,

Gemeinde Demitz-Thumitz, sofern nicht bereits Teil der Sperrzone II,

Gemeinde Doberschau-Gaußig,

Gemeinde Göda, sofern nicht bereits Teil der Sperrzone II,

Gemeinde Großharthau, sofern nicht bereits Teil der Sperrzone II,

Gemeinde Großpostwitz/O.L.,

Gemeinde Hochkirch, sofern nicht bereits der Sperrzone II,

Gemeinde Kubschütz, sofern nicht bereits Teil der Sperrzone II,

Gemeinde Neukirch/Lausitz,

Gemeinde Obergurig,

Gemeinde Schmölln-Putzkau,

Gemeinde Sohland a. d. Spree,

Gemeinde Stadt Bautzen, sofern nicht bereits Teil der Sperrzone II,

Gemeinde Stadt Bischhofswerda, sofern nicht bereits Teil der Sperrzone II,

Gemeinde Stadt Radeberg, sofern nicht bereits Teil der Sperrzone II,

Gemeinde Stadt Schirgiswalde-Kirschau,

Gemeinde Stadt Wilthen,

Gemeinde Steinigtwolmsdorf,

Stadt Dresden:

Stadtgebiet, sofern nicht bereits Teil der Sperrzone II,

Landkreis Meißen:

Gemeinde Diera-Zehren, sofern nicht bereits Teil der Sperrzone II,

Gemeinde Glaubitz, sofern nicht bereits Teil der Sperrzone II,

Gemeinde Hirschstein,

Gemeinde Käbschütztal,

Gemeinde Klipphausen, sofern nicht bereits Teil der Sperrzone II,

Gemeinde Niederau, sofern nicht bereits Teil der Sperrzone II,

Gemeinde Nünchritz, sofern nicht bereits Teil der Sperrzone II,

Gemeinde Röderaue, sofern nicht bereits Teil der Sperrzone II,

Gemeinde Stadt Gröditz, sofern nicht bereits Teil der Sperrzone II,

Gemeinde Stadt Lommatzsch,

Gemeinde Stadt Meißen, sofern nicht bereits Teil der Sperrzone II,

Gemeinde Stadt Nossen außer Ortsteil Nossen,

Gemeinde Stadt Riesa,

Gemeinde Stadt Strehla,

Gemeinde Stauchitz,

Gemeinde Wülknitz, sofern nicht bereits Teil der Sperrzone II,

Gemeinde Zeithain,

Landkreis Mittelsachsen:

Gemeinde Reinsberg,

Landkreis Sächsische Schweiz-Osterzgebirge:

Gemeinde Bannewitz,

Gemeinde Dürrröhrsdorf-Dittersbach,

Gemeinde Kreischa,

Gemeinde Lohmen,

Gemeinde Müglitztal,

Gemeinde Stadt Dohna,

Gemeinde Stadt Freital,

Gemeinde Stadt Heidenau,

Gemeinde Stadt Hohnstein,

Gemeinde Stadt Neustadt i. Sa.,

Gemeinde Stadt Pirna,

Gemeinde Stadt Rabenau mit den Ortsteilen Lübau, Obernaundorf, Oelsa, Rabenau und Spechtritz,

Gemeinde Stadt Stolpen,

Gemeinde Stadt Tharandt mit den Ortsteilen Fördergersdorf, Großopitz, Kurort Hartha, Pohrsdorf und Spechtshausen,

Gemeinde Stadt Wilsdruff, sofern nicht bereits Teil der Sperrzone II,

Bundesland Mecklenburg-Vorpommern:

Landkreis Vorpommern Greifswald

Gemeinde Penkun südlich der Autobahn A11,

Gemeinde Nadrense südlich der Autobahn A11,

Landkreis Ludwigslust-Parchim:

Gemeinde Barkhagen mit den Ortsteilen und Ortslagen: Altenlinden, Kolonie Lalchow, Plauerhagen, Zarchlin, Barkow-Ausbau, Barkow,

Gemeinde Blievenstorf mit dem Ortsteil: Blievenstorf,

Gemeinde Brenz mit den Ortsteilen und Ortslagen: Neu Brenz, Alt Brenz,

Gemeinde Domsühl mit den Ortsteilen und Ortslagen: Severin, Bergrade Hof, Bergrade Dorf, Zieslübbe, Alt Dammerow, Schlieven, Domsühl, Domsühl-Ausbau, Neu Schlieven,

Gemeinde Gallin-Kuppentin mit den Ortsteilen und Ortslagen: Kuppentin, Kuppentin-Ausbau, Daschow, Zahren, Gallin, Penzlin,

Gemeinde Ganzlin mit den Ortsteilen und Ortslagen: Dresenow, Dresenower Mühle, Twietfort, Ganzlin, Tönchow, Wendisch Priborn, Liebhof, Gnevsdorf,

Gemeinde Granzin mit den Ortsteilen und Ortslagen: Lindenbeck, Greven, Beckendorf, Bahlenrade, Granzin,

Gemeinde Grabow mit den Ortsteilen und Ortslagen: Fresenbrügge, Grabow, Griemoor, Heidehof, Kaltehof, Winkelmoor,

Gemeinde Groß Laasch mit den Ortsteilen und Ortslagen: Groß Laasch,

Gemeinde Kremmin mit den Ortsteilen und Ortslagen: Beckentin, Kremmin,

Gemeinde Kritzow mit den Ortsteilen und Ortslagen: Schlemmin, Kritzow,

Gemeinde Lewitzrand mit dem Ortsteil und Ortslage: Matzlow-Garwitz (teilweise),

Gemeinde Lübz mit den Ortsteilen und Ortslagen: Bobzin, Broock, Broock Ausbau, Hof Gischow, Lübz, Lutheran, Lutheran Ausbau, Riederfelde, Ruthen, Wessentin, Wessentin Ausbau,

Gemeinde Neustadt-Glewe mit den Ortsteilen und Ortslagen: Hohes Feld, Kiez, Klein Laasch, Liebs Siedlung, Neustadt-Glewe, Tuckhude, Wabel,

Gemeinde Obere Warnow mit den Ortsteilen und Ortslagen: Grebbin und Wozinkel, Gemarkung Kossebade teilweise, Gemarkung Herzberg mit dem Waldgebiet Bahlenholz bis an die östliche Gemeindegrenze, Gemarkung Woeten unmittelbar östlich und westlich der L16,

Gemeinde Parchim mit den Ortsteilen und Ortslagen: Dargelütz, Neuhof, Kiekindemark, Neu Klockow, Möderitz, Malchow, Damm, Parchim, Voigtsdorf, Neu Matzlow,

Gemeinde Passow mit den Ortsteilen und Ortslagen: Unterbrüz, Brüz, Welzin, Neu Brüz, Weisin, Charlottenhof, Passow,

Gemeinde Plau am See mit den Ortsteilen und Ortslagen: Reppentin, Gaarz, Silbermühle, Appelburg, Seelust, Plau-Am See, Plötzenhöhe, Klebe, Lalchow, Quetzin, Heidekrug,

Gemeinde Rom mit den Ortsteilen und Ortslagen: Lancken, Stralendorf, Rom, Darze, Paarsch,

Gemeinde Spornitz mit den Ortsteilen und Ortslagen: Dütschow, Primark, Steinbeck, Spornitz,

Gemeinde Werder mit den Ortsteilen und Ortslagen: Neu Benthen, Benthen, Tannenhof, Werder.

2.   Estonia

The following restricted zones I in Estonia:

Hiiu maakond.

3.   Greece

The following restricted zones I in Greece:

in the regional unit of Drama:

the community departments of Sidironero and Skaloti and the municipal departments of Livadero and Ksiropotamo (in Drama municipality),

the municipal department of Paranesti (in Paranesti municipality),

the municipal departments of Kokkinogeia, Mikropoli, Panorama, Pyrgoi (in Prosotsani municipality),

the municipal departments of Kato Nevrokopi, Chrysokefalo, Achladea, Vathytopos, Volakas, Granitis, Dasotos, Eksohi, Katafyto, Lefkogeia, Mikrokleisoura, Mikromilea, Ochyro, Pagoneri, Perithorio, Kato Vrontou and Potamoi (in Kato Nevrokopi municipality),

in the regional unit of Xanthi:

the municipal departments of Kimmerion, Stavroupoli, Gerakas, Dafnonas, Komnina, Kariofyto and Neochori (in Xanthi municipality),

the community departments of Satres, Thermes, Kotyli, and the municipal departments of Myki, Echinos and Oraio and (in Myki municipality),

the community department of Selero and the municipal department of Sounio (in Avdira municipality),

in the regional unit of Rodopi:

the municipal departments of Komotini, Anthochorio, Gratini, Thrylorio, Kalhas, Karydia, Kikidio, Kosmio, Pandrosos, Aigeiros, Kallisti, Meleti, Neo Sidirochori and Mega Doukato (in Komotini municipality),

the municipal departments of Ipio, Arriana, Darmeni, Archontika, Fillyra, Ano Drosini, Aratos and the Community Departments Kehros and Organi (in Arriana municipality),

the municipal departments of Iasmos, Sostis, Asomatoi, Polyanthos and Amvrosia and the community department of Amaxades (in Iasmos municipality),

the municipal department of Amaranta (in Maroneia Sapon municipality),

in the regional unit of Evros:

the municipal departments of Kyriaki, Mandra, Mavrokklisi, Mikro Dereio, Protokklisi, Roussa, Goniko, Geriko, Sidirochori, Megalo Derio, Sidiro, Giannouli, Agriani and Petrolofos (in Soufli municipality),

the municipal departments of Dikaia, Arzos, Elaia, Therapio, Komara, Marasia, Ormenio, Pentalofos, Petrota, Plati, Ptelea, Kyprinos, Zoni, Fulakio, Spilaio, Nea Vyssa, Kavili, Kastanies, Rizia, Sterna, Ampelakia, Valtos, Megali Doxipara, Neochori and Chandras (in Orestiada municipality),

the municipal departments of Asvestades, Ellinochori, Karoti, Koufovouno, Kiani, Mani, Sitochori, Alepochori, Asproneri, Metaxades, Vrysika, Doksa, Elafoxori, Ladi, Paliouri and Poimeniko (in Didymoteixo municipality),

in the regional unit of Serres:

the municipal departments of Kerkini, Livadia, Makrynitsa, Neochori, Platanakia, Petritsi, Akritochori, Vyroneia, Gonimo, Mandraki, Megalochori, Rodopoli, Ano Poroia, Katw Poroia, Sidirokastro, Vamvakophyto, Promahonas, Kamaroto, Strymonochori, Charopo, Kastanousi and Chortero and the community departments of Achladochori, Agkistro and Kapnophyto (in Sintiki municipality),

the municipal departments of Serres, Elaionas and Oinoussa and the community departments of Orini and Ano Vrontou (in Serres municipality),

the municipal departments of Dasochoriou, Irakleia, Valtero, Karperi, Koimisi, Lithotopos, Limnochori, Podismeno and Chrysochorafa (in Irakleia municipality).

4.   Latvia

The following restricted zones I in Latvia:

Dienvidkurzemes novada, Grobiņas pagasts, Nīcas pagasta daļa uz ziemeļiem no apdzīvotas vietas Bernāti, autoceļa V1232, A11, V1222, Bārtas upes, Otaņķu pagasts, Grobiņas pilsēta,

Ropažu novada Stopiņu pagasta daļa, kas atrodas uz rietumiem no autoceļa V36, P4 un P5, Acones ielas, Dauguļupes ielas un Dauguļupītes.

5.   Lithuania

The following restricted zones I in Lithuania:

Kalvarijos savivaldybė,

Klaipėdos rajono savivaldybė: Agluonėnų, Dovilų, Gargždų, Priekulės, Vėžaičių, Kretingalės ir Dauparų-Kvietinių seniūnijos,

Marijampolės savivaldybė,

Palangos miesto savivaldybė,

Vilkaviškio rajono savivaldybė.

6.   Hungary

The following restricted zones I in Hungary:

Békés megye 950950, 950960, 950970, 951950, 952050, 952750, 952850, 952950, 953050, 953150, 953650, 953660, 953750, 953850, 953960, 954250, 954260, 954350, 954450, 954550, 954650, 954750, 954850, 954860, 954950, 955050, 955150, 955250, 955260, 955270, 955350, 955450, 955510, 955650, 955750, 955760, 955850, 955950, 956050, 956060, 956150 és 956160 kódszámú vadgazdálkodási egységeinek teljes területe,

Bács-Kiskun megye 600150, 600850, 601550, 601650, 601660, 601750, 601850, 601950, 602050, 603250, 603750 és 603850 kódszámú vadgazdálkodási egységeinek teljes területe,

Budapest 1 kódszámú, vadgazdálkodási tevékenységre nem alkalmas területe,

Csongrád-Csanád megye 800150, 800160, 800250, 802220, 802260, 802310 és 802450 kódszámú vadgazdálkodási egységeinek teljes területe,

Fejér megye 400150, 400250, 400351, 400352, 400450, 400550, 401150, 401250, 401350, 402050, 402350, 402360, 402850, 402950, 403050, 403450, 403550, 403650, 403750, 403950, 403960, 403970, 404650, 404750, 404850, 404950, 404960, 405050, 405750, 405850, 405950,

406050, 406150, 406550, 406650 és 406750 kódszámú vadgazdálkodási egységeinek teljes területe,

Győr-Moson-Sopron megye 100550, 100650, 100950, 101050, 101350, 101450, 101550, 101560 és 102150 kódszámú vadgazdálkodási egységeinek teljes területe,

Jász-Nagykun-Szolnok megye 750150, 750160, 750260, 750350, 750450, 750460, 754450, 754550, 754560, 754570, 754650, 754750, 754950, 755050, 755150, 755250, 755350 és 755450 kódszámú vadgazdálkodási egységeinek teljes területe,

Komárom-Esztergom megye 250150, 250250, 250450, 250460, 250550, 250650, 250750, 251050, 251150, 251250, 251350, 251360, 251650, 251750, 251850, 252250, kódszámú vadgazdálkodási egységeinek teljes területe,

Pest megye 571550, 572150, 572250, 572350, 572550, 572650, 572750, 572850, 572950, 573150, 573250, 573260, 573350, 573360, 573450, 573850, 573950, 573960, 574050, 574150, 574350, 574360, 574550, 574650, 574750, 574850, 574860, 574950, 575050, 575150, 575250, 575350, 575550, 575650, 575750, 575850, 575950, 576050, 576150, 576250, 576350, 576450, 576650, 576750, 576850, 576950, 577050, 577150, 577350, 577450, 577650, 577850, 577950, 578050, 578150, 578250, 578350, 578360, 578450, 578550, 578560, 578650, 578850, 578950, 579050, 579150, 579250, 579350, 579450, 579460, 579550, 579650, 579750, 580250 és 580450 kódszámú vadgazdálkodási egységeinek teljes területe.

7.   Poland

The following restricted zones I in Poland:

w województwie kujawsko - pomorskim:

powiat rypiński,

powiat brodnicki,

powiat grudziądzki,

powiat miejski Grudziądz,

powiat wąbrzeski,

w województwie warmińsko-mazurskim:

gminy Wielbark i Rozogi w powiecie szczycieńskim,

w województwie podlaskim:

gminy Wysokie Mazowieckie z miastem Wysokie Mazowieckie, Czyżew i część gminy Kulesze Kościelne położona na południe od linii wyznaczonej przez linię kolejową w powiecie wysokomazowieckim,

gminy Miastkowo, Nowogród, Śniadowo i Zbójna w powiecie łomżyńskim,

gminy Szumowo, Zambrów z miastem Zambrów i część gminy Kołaki Kościelne położona na południe od linii wyznaczonej przez linię kolejową w powiecie zambrowskim,

gminy Grabowo, Kolno i miasto Kolno, Turośl w powiecie kolneńskim,

w województwie mazowieckim:

powiat ostrołęcki,

powiat miejski Ostrołęka,

gminy Bielsk, Brudzeń Duży, Bulkowo, Drobin, Gąbin, Łąck, Nowy Duninów, Radzanowo, Słupno, Staroźreby i Stara Biała w powiecie płockim,

powiat miejski Płock,

powiat ciechanowski,

gminy Baboszewo, Dzierzążnia, Joniec, Nowe Miasto, Płońsk i miasto Płońsk, Raciąż i miasto Raciąż, Sochocin w powiecie płońskim,

powiat sierpecki,

gmina Bieżuń, Lutocin, Siemiątkowo i Żuromin w powiecie żuromińskim,

część powiatu ostrowskiego niewymieniona w części II załącznika I,

gminy Dzieżgowo, Lipowiec Kościelny, Mława, Radzanów, Strzegowo, Stupsk, Szreńsk, Szydłowo, Wiśniewo w powiecie mławskim,

powiat przasnyski,

powiat makowski,

powiat pułtuski,

część powiatu wyszkowskiego niewymieniona w części II załącznika I,

część powiatu węgrowskiego niewymieniona w części II załącznika I,

część powiatu wołomińskiego niewymieniona w części II załącznika I,

gminy Mokobody i Suchożebry w powiecie siedleckim,

gminy Dobre, Jakubów, Kałuszyn, Stanisławów w powiecie mińskim,

gminy Bielany i gmina wiejska Sokołów Podlaski w powiecie sokołowskim,

powiat gostyniński,

w województwie podkarpackim:

powiat jasielski,

powiat strzyżowski,

część powiatu ropczycko – sędziszowskiego niewymieniona w części II i II załącznika I,

gminy Pruchnik, Rokietnica, Roźwienica, w powiecie jarosławskim,

gminy Fredropol, Krasiczyn, Krzywcza, Przemyśl, część gminy Orły położona na zachód od linii wyznaczonej przez drogę nr 77, część gminy Żurawica na zachód od linii wyznaczonej przez drogę nr 77 w powiecie przemyskim,

powiat miejski Przemyśl,

gminy Gać, Jawornik Polski, Kańczuga, część gminy Zarzecze położona na południe od linii wyznaczonej przez rzekę Mleczka w powiecie przeworskim,

powiat łańcucki,

gminy Trzebownisko, Głogów Małopolski, część gminy Świlcza położona na północ od linii wyznaczonej przez drogę nr 94 i część gminy Sokołów Małopolski położona na południe od linii wyznaczonej przez drogę nr 875 w powiecie rzeszowskim,

gmina Raniżów w powiecie kolbuszowskim,

gminy Brzostek, Jodłowa, Pilzno, miasto Dębica, część gminy Czarna położona na południe od linii wyznaczonej przez drogę nr A4, część gminy Żyraków położona na południe od linii wyznaczonej przez drogę nr A4, część gminy wiejskiej Dębica położona na południe od linii wyznaczonej przez drogę nr A4 w powiecie dębickim,

w województwie świętokrzyskim:

gminy Nowy Korczyn, Solec–Zdrój, Wiślica, Stopnica, Tuczępy, Busko Zdrój w powiecie buskim,

powiat kazimierski,

powiat skarżyski,

część powiatu opatowskiego niewymieniona w części II załącznika I,

część powiatu sandomierskiego niewymieniona w części II załącznika I,

gminy Bogoria, Osiek, Staszów i część gminy Rytwiany położona na wschód od linii wyznaczonej przez drogę nr 764, część gminy Szydłów położona na wschód od linii wyznaczonej przez drogę nr 756 w powiecie staszowskim,

gminy Pawłów, Wąchock, część gminy Brody położona na zachód od linii wyznaczonej przez drogę nr 9 oraz na południowy - zachód od linii wyznaczonej przez drogi: nr 0618T biegnącą od północnej granicy gminy do skrzyżowania w miejscowości Lipie, drogę biegnącą od miejscowości Lipie do wschodniej granicy gminy i część gminy Mirzec położona na zachód od linii wyznaczonej przez drogę nr 744 biegnącą od południowej granicy gminy do miejscowości Tychów Stary a następnie przez drogę nr 0566T biegnącą od miejscowości Tychów Stary w kierunku północno - wschodnim do granicy gminy w powiecie starachowickim,

powiat ostrowiecki,

gminy Fałków, Ruda Maleniecka, Radoszyce, Smyków, Słupia Konecka, część gminy Końskie położona na zachód od linii kolejowej, część gminy Stąporków położona na południe od linii kolejowej w powiecie koneckim,

gminy Bodzentyn, Bieliny, Łagów, Morawica, Nowa Słupia, część gminy Raków położona na wschód od linii wyznaczonej przez drogi nr 756 i 764, część gminy Chęciny położona na południe od linii wyznaczonej przez drogę nr 762, część gminy Górno położona na południe od linii wyznaczonej przez drogę biegnącą od wschodniej granicy gminy łączącą miejscowości Leszczyna – Cedzyna oraz na południe od linii wyznaczonej przez ul. Kielecką w miejscowości Cedzyna biegnącą do wschodniej granicy gminy, część gminy Daleszyce położona na północ od linii wyznaczonej przez drogę nr 764 biegnącą od wschodniej granicy gminy do skrzyżowania z drogą łączącą miejscowości Daleszyce – Słopiec – Borków, dalej na północ od linii wyznaczonej przez tę drogę biegnącą od skrzyżowania z drogą nr 764 do przecięcia z linią rzeki Belnianka, następnie na północ od linii wyznaczonej przez rzeki Belnianka i Czarna Nida biegnącej do zachodniej granicy gminy w powiecie kieleckim,

gminy Działoszyce, Michałów, Pińczów, Złota w powiecie pińczowskim,

gminy Imielno, Jędrzejów, Nagłowice, Sędziszów, Słupia, Sobków, Wodzisław w powiecie jędrzejowskim,

gminy Moskorzew, Radków, Secemin, część gminy Włoszczowa położona na zachód od linii wyznaczonej przez drogę nr 742 biegnącą od północnej granicy gminy do miejscowości Konieczno, i dalej na zachód od linii wyznaczonej przez drogę łączącą miejscowości Konieczno – Rogienice – Dąbie – Podłazie, część gminy Kluczewsko położona na północ od linii wyznaczonej przez drogę biegnącą od wschodniej granicy gminy i łączącą miejscowości Krogulec – Nowiny - Komorniki do przecięcia z linią rzeki Czarna, następnie na północ od linii wyznaczonej przez rzekę Czarna biegnącą do przecięcia z linią wyznaczoną przez drogę nr 742 i dalej na zachód od linii wyznaczonej przez drogę nr 742 biegnącą od przecięcia z linią rzeki Czarna do południowej granicy gminy w powiecie włoszczowskim,

w województwie łódzkim:

gminy Łyszkowice, Kocierzew Południowy, Kiernozia, Chąśno, Nieborów, część gminy wiejskiej Łowicz położona na północ od linii wyznaczonej przez drogę nr 92 biegnącej od granicy miasta Łowicz do zachodniej granicy gminy oraz część gminy wiejskiej Łowicz położona na wschód od granicy miasta Łowicz i na północ od granicy gminy Nieborów w powiecie łowickim,

gminy Cielądz, Rawa Mazowiecka z miastem Rawa Mazowiecka w powiecie rawskim,

gminy Bolimów, Głuchów, Godzianów, Lipce Reymontowskie, Maków, Nowy Kawęczyn, Skierniewice, Słupia w powiecie skierniewickim,

powiat miejski Skierniewice,

gminy Mniszków, Paradyż, Sławno i Żarnów w powiecie opoczyńskim,

powiat tomaszowski,

powiat brzeziński,

powiat łaski,

powiat miejski Łódź,

powat łódzki wschodni,

powiat pabianicki,

powiat wieruszowski,

gminy Aleksandrów Łódzki, Stryków, miasto Zgierz w powiecie zgierskim,

gminy Bełchatów z miastem Bełchatów, Drużbice, Kluki, Rusiec, Szczerców, Zelów w powiecie bełchatowskim,

powiat wieluński,

powiat sieradzki,

powiat zduńskowolski,

gminy Aleksandrów, Czarnocin, Grabica, Moszczenica, Ręczno, Sulejów, Wola Krzysztoporska, Wolbórz w powiecie piotrkowskim,

powiat miejski Piotrków Trybunalski,

gminy Masłowice, Przedbórz, Wielgomłyny i Żytno w powiecie radomszczańskim,

w województwie śląskim:

gmina Koniecpol w powiecie częstochowskim,

w województwie pomorskim:

gminy Ostaszewo, miasto Krynica Morska oraz część gminy Nowy Dwór Gdański położona na południowy - zachód od linii wyznaczonej przez drogę nr 55 biegnącą od południowej granicy gminy do skrzyżowania z drogą nr 7, następnie przez drogę nr 7 i S7 biegnącą do zachodniej granicy gminy w powiecie nowodworskim,

gminy Lichnowy, Miłoradz, Malbork z miastem Malbork, część gminy Nowy Staw położna na zachód od linii wyznaczonej przez drogę nr 55 w powiecie malborskim,

gminy Mikołajki Pomorskie, Stary Targ i Sztum w powiecie sztumskim,

powiat gdański,

Miasto Gdańsk,

powiat tczewski,

powiat kwidzyński,

w województwie lubuskim:

gmina Lubiszyn w powiecie gorzowskim,

gmina Dobiegniew w powiecie strzelecko – drezdeneckim,

w województwie dolnośląskim:

gminy Dziadowa Kłoda, Międzybórz, Syców, Twardogóra, część gminy wiejskiej Oleśnica położona na północ od linii wyznaczonej przez drogę nr S8, część gminy Dobroszyce położona na wschód od linii wyznaczonej przez linię kolejową biegnącą od północnej do południowej granicy gminy w powiecie oleśnickim,

gminy Jordanów Śląski, Kobierzyce, Mietków, Sobótka, część gminy Żórawina położona na zachód od linii wyznaczonej przez autostradę A4, część gminy Kąty Wrocławskie położona na południe od linii wyznaczonej przez autostradę A4 w powiecie wrocławskim,

część gminy Domaniów położona na południowy zachód od linii wyznaczonej przez autostradę A4 w powiecie oławskim,

gmina Wiązów w powiecie strzelińskim,

część powiatu średzkiego niewymieniona w części II załącznika I,

miasto Świeradów - Zdrój w powiecie lubańskim,

gminy Pielgrzymka, miasto Złotoryja, część gminy wiejskiej Złotoryja położona na zachód od linii wyznaczonej przez drogę biegnącą od północnej granicy gminy w miejscowości Nowa Wieś Złotoryjska do granicy miasta Złotoryja oraz na południe od linii wyznaczonej przez drogę nr 382 biegnącą od granicy miasta Złotoryja do wschodniej granicy gminy w powiecie złotoryjskim,

gmina Mirsk w powiecie lwóweckim,

gminy Janowice Wielkie, Mysłakowice, Stara Kamienica w powiecie karkonoskim,

część powiatu miejskiego Jelenia Góra położona na północ od linii wyznaczonej przez drogę nr 366,

gminy Bolków, Męcinka, Mściwojów, Paszowice, miasto Jawor w powiecie jaworskim,

gminy Dobromierz, Jaworzyna Śląska, Marcinowice, Strzegom, Żarów w powiecie świdnickim,

gminy Dzierżoniów, Pieszyce, miasto Bielawa, miasto Dzierżoniów w powiecie dzierżoniowskim,

gminy Głuszyca, Mieroszów w powiecie wałbrzyskim,

gmina Nowa Ruda i miasto Nowa Ruda w powiecie kłodzkim,

gminy Kamienna Góra, Marciszów i miasto Kamienna Góra w powiecie kamiennogórskim,

w województwie wielkopolskim:

gminy Koźmin Wielkopolski, Rozdrażew, miasto Sulmierzyce, część gminy Krotoszyn położona na wschód od linii wyznaczonej przez drogi: nr 15 biegnącą od północnej granicy gminy do skrzyżowania z drogą nr 36, nr 36 biegnącą od skrzyżowania z drogą nr 15 do skrzyżowana z drogą nr 444, nr 444 biegnącą od skrzyżowania z drogą nr 36 do południowej granicy gminy w powiecie krotoszyńskim,

gminy Brodnica, część gminy Dolsk położona na wschód od linii wyznaczonej przez drogę nr 434 biegnącą od północnej granicy gminy do skrzyżowania z drogą nr 437, a nastęnie na wschód od drogi nr 437 biegnącej od skrzyżowania z drogąnr 434 do południowej granicy gminy, część gminy Śrem położóna na wschód od linii wyznaczonej przez drogę nr 310 biegnącą od zachodniej granicy gminy do miejscowości Śrem, następnie na wschód od drogi nr 432 w miejscowości Śrem oraz na wschód od drogi nr 434 biegnącej od skrzyżowania z drogą nr 432 do południowej granicy gminy w powiecie śremskim,

gminy Borek Wielkopolski, Piaski, Pogorzela, w powiecie gostyńskim,

gmina Grodzisk Wielkopolski i część gminy Kamieniec położona na wschód od linii wyznaczonej przez drogę nr 308 w powiecie grodziskim,

gminy Czempiń, Kościan i miasto Kościan w powiecie kościańskim,

gminy Kleszczewo, Kostrzyn, Kórnik, Pobiedziska, Mosina, miasto Puszczykowo, część gminy wiejskiej Murowana Goślina położona na południe od linii kolejowej biegnącej od północnej granicy miasta Murowana Goślina do północno-wschodniej granicy gminy w powiecie poznańskim,

gmina Kiszkowo i część gminy Kłecko położona na zachód od rzeki Mała Wełna w powiecie gnieźnieńskim,

powiat czarnkowsko-trzcianecki,

część gminy Wronki położona na północ od linii wyznaczonej przez rzekę Wartę biegnącą od zachodniej granicy gminy do przecięcia z droga nr 182, a następnie na wschód od linii wyznaczonej przez drogi nr 182 oraz 184 biegnącą od skrzyżowania z drogą nr 182 do południowej granicy gminy w powiecie szamotulskim,

gmina Budzyń w powiecie chodzieskim,

gminy Mieścisko, Skoki i Wągrowiec z miastem Wągrowiec w powiecie wągrowieckim,

powiat pleszewski,

gmina Zagórów w powiecie słupeckim,

gmina Pyzdry w powiecie wrzesińskim,

gminy Kotlin, Żerków i część gminy Jarocin położona na wschód od linii wyznaczonej przez drogi nr S11 i 15 w powiecie jarocińskim,

powiat ostrowski,

powiat miejski Kalisz,

powiat kaliski,

powiat turecki,

gminy Rzgów, Grodziec, Krzymów, Stare Miasto, Rychwał w powiecie konińskim,

powiat kępiński,

powiat ostrzeszowski,

w województwie opolskim:

gminy Domaszowice, Pokój, część gminy Namysłów położona na północ od linii wyznaczonej przez linię kolejową biegnącą od wschodniej do zachodniej granicy gminy w powiecie namysłowskim,

gminy Wołczyn, Kluczbork, Byczyna w powiecie kluczborskim,

gminy Praszka, Gorzów Śląski część gminy Rudniki położona na północ od linii wyznaczonej przez drogę nr 42 biegnącą od zachodniej granicy gminy do skrzyżowania z drogą nr 43 i na zachód od linii wyznaczonej przez drogę nr 43 biegnącą od północnej granicy gminy do skrzyżowania z drogą nr 42 w powiecie oleskim,

gmina Grodkóww powiecie brzeskim,

gminy Komprachcice, Łubniany, Murów, Niemodlin, Tułowice w powiecie opolskim,

powiat miejski Opole,

w województwie zachodniopomorskim:

gminy Nowogródek Pomorski, Barlinek, Myślibórz, część gminy Dębno położona na wschód od linii wyznaczonej przez drogę nr 126 biegnącą od zachodniej granicy gminy do skrzyżowania z drogą nr 23 w miejscowości Dębno, następnie na wschód od linii wyznaczonej przez drogę nr 23 do skrzyżowania z ul. Jana Pawła II w miejscowości Cychry, następnie na północ od ul. Jana Pawła II do skrzyżowania z ul. Ogrodową i dalej na północ od linii wyznaczonej przez ul. Ogrodową, której przedłużenie biegnie do wschodniej granicy gminy w powiecie myśliborskim,

gmina Stare Czarnowo w powiecie gryfińskim,

gmina Bielice, Kozielice, Pyrzyce w powiecie pyrzyckim,

gminy Bierzwnik, Krzęcin, Pełczyce w powiecie choszczeńskim,

część powiatu miejskiego Szczecin położona na zachód od linii wyznaczonej przez rzekę Odra Zachodnia biegnącą od północnej granicy gminy do przecięcia z drogą nr 10, następnie na południe od linii wyznaczonej przez drogę nr 10 biegnącą od przecięcia z linią wyznaczoną przez rzekę Odra Zachodnia do wschodniej granicy gminy,

gminy Dobra (Szczecińska), Kołbaskowo, Police w powiecie polickim,

w województwie małopolskim:

powiat brzeski,

powiat gorlicki,

powiat proszowicki,

część powiatu nowosądeckiego niewymieniona w części II załącznika I,

gminy Czorsztyn, Krościenko nad Dunajcem, Ochotnica Dolna w powiecie nowotarskim,

powiat miejski Nowy Sącz,

powiat tarnowski,

powiat miejski Tarnów,

część powiatu dąbrowskiego niewymieniona w części III załącznika I.